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EQUUS CABALLUS SKIN- horse epithelia injection, solutionCEIBA PENTANDRA FIBER- kapok injection, solutionMUS MUSCULUS SKIN- mouse epithelia injection, solutionORRIS- iris x germanica root injection, solutionRABBIT injection, solutionPERIPLANETA AMERICANA- american cockroach injec .......SE DUST injection, solutionBOS TAURUS SKIN- cattle epithelia injection, solutionCOTTON FIBER- cotton linters injection, solutionCOTTON SEED- cottonseed injection, solutionCANIS LUPUS FAMILIARIS SKIN- dog epithelia injection, solutionCAVIA PORCELLUS SKIN- guinea pig epithelia injection, solution


  1. No Title 1572550560
  2. Warning
  3. Description
  4. Clinical Pharmacology
  5. Indications And Usage
  6. Contraindications
  7. Warnings
  8. Precautions
  9. Adverse Reactions
  10. Overdosage
  11. Dosage And Administration
  12. How Supplied
  13. References
  14. No Title 1572449379

No Title 1572550560 

Principal Display Panel
Allergenic Extract
mL sterile multiple dose vial
ALK ABELLO

Allergenic Extract mL sterile multiple dose vial ALK ABELLO

EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0630
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0630-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0631
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0631-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0631-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0632
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0632-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0656
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0656-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0656-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CEIBA PENTANDRA FIBER
kapok injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0635
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEIBA PENTANDRA FIBER (UNII: 758Z9H9WV9) (CEIBA PENTANDRA FIBER - UNII:758Z9H9WV9) CEIBA PENTANDRA FIBER 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0635-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0635-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUS MUSCULUS SKIN
mouse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0638
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUS MUSCULUS SKIN (UNII: 390AN9GB09) (MUS MUSCULUS SKIN - UNII:390AN9GB09) MUS MUSCULUS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0638-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0638-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUS MUSCULUS SKIN
mouse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0639
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUS MUSCULUS SKIN (UNII: 390AN9GB09) (MUS MUSCULUS SKIN - UNII:390AN9GB09) MUS MUSCULUS SKIN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0639-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ORRIS
iris x germanica root injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0642
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRIS X GERMANICA ROOT (UNII: 8N6VTJ9IWV) (IRIS X GERMANICA ROOT - UNII:8N6VTJ9IWV) IRIS X GERMANICA ROOT 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0642-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0642-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RABBIT
rabbit injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0649
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0649-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RABBIT
rabbit injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0650
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0650-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0650-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RABBIT
rabbit injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0651
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0651-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0651-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0705
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0705-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0706
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0706-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0706-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0707
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0707-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0707-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0708
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0708-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0709
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0709-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0710
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0710-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0711
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0711-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0714
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0714-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0714-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0715
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0715-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0716
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0716-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0717
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0717-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0718
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0718-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0719
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0719-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0719-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0720
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0720-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0721
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0721-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACREMONIUM STRICTUM
sarocladium strictum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0800
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0800-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACREMONIUM STRICTUM
sarocladium strictum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0801
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0801-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0801-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACREMONIUM STRICTUM
sarocladium strictum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0802
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0802-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACREMONIUM STRICTUM
sarocladium strictum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0803
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0803-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0803-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0805
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0805-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0806
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0806-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0807
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0807-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0807-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0808
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0808-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0808-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0809
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0809-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0809-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0810
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0810-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0811
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0811-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0812
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0812-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0812-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0813
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.02 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0813-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0814
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0814-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0815
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0815-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0815-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0816
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0816-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0816-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0817
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0817-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0817-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3 NDC:0268-0817-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0818
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0818-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0818-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0819
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0819-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0819-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0820
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0820-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0821
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0821-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0822
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0822-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0823
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.02 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0823-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0824
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0824-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0825
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0825-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0825-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0826
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0826-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0826-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS NIGER VAR NIGER
aspergillus niger injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0827
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0827-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0827-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS NIGER VAR NIGER
aspergillus niger injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0828
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0828-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0828-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS NIGER VAR NIGER
aspergillus niger injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0829
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0829-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS NIGER VAR NIGER
aspergillus niger injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0830
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0830-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0830-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AUREOBASIDIUM PULLULANS VAR PULLULANS
pullularia pullulans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0832
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0832-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0832-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3 NDC:0268-0832-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AUREOBASIDIUM PULLULANS VAR PULLULANS
pullularia pullulans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0833
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0833-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0833-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AUREOBASIDIUM PULLULANS VAR PULLULANS
pullularia pullulans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0834
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0834-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0834-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AUREOBASIDIUM PULLULANS VAR PULLULANS
pullularia pullulans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0835
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0835-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0835-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AUREOBASIDIUM PULLULANS VAR PULLULANS
pullularia pullulans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0836
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0836-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0836-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOTRYTIS CINEREA
botrytis cinerea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0837
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0837-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0837-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOTRYTIS CINEREA
botrytis cinerea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0838
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0838-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOTRYTIS CINEREA
botrytis cinerea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0839
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0839-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOTRYTIS CINEREA
botrytis cinerea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0840
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0840-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0840-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOTRYTIS CINEREA
botrytis cinerea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0841
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0841-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0842
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0842-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0843
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0843-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0843-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0844
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0844-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0844-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0845
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0845-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0845-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0846
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0846-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0847
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0847-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0848
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.02 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0848-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0849
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0849-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0849-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0850
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0850-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHAETOMIUM GLOBOSUM
chaetomium globosum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0851
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0851-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0851-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHAETOMIUM GLOBOSUM
chaetomium globosum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0852
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0852-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0852-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHAETOMIUM GLOBOSUM
chaetomium globosum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0853
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0853-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0853-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0855
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0855-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0855-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0856
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0856-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0856-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0857
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0857-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0857-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0858
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0858-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0859
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0859-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0860
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0860-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0861
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0861-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0861-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0863
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0863-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0863-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0864
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0864-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0864-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0865
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0865-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0865-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0866
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0866-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0867
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0867-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0868
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0868-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0868-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0869
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0869-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0870
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0870-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0870-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0871
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0871-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0871-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0878
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0878-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0878-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0879
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0879-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0879-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0880
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0880-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0880-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0881
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0881-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0882
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0882-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0882-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0883
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0883-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0884
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0884-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0884-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3 NDC:0268-0884-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0885
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0885-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0885-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0886
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0886-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0886-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0887
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0887-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0888
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0888-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0889
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0889-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0890
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0890-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0891
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0891-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0892
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0892-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0892-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0893
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0893-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0894
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0894-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0894-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0895
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0895-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0895-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0896
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0896-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0896-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0897
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0897-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0898
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0898-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0899
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0899-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0899-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0900
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0900-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0901
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0901-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0901-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0902
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0902-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0902-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HELMINTHOSPORIUM SOLANI
helminthosporium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0903
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0903-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HELMINTHOSPORIUM SOLANI
helminthosporium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0904
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0904-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HELMINTHOSPORIUM SOLANI
helminthosporium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0905
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0905-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HELMINTHOSPORIUM SOLANI
helminthosporium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0906
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0906-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUCOR PLUMBEUS
mucor plumbeus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0911
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0911-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0911-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUCOR PLUMBEUS
mucor plumbeus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0912
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0912-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0912-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUCOR PLUMBEUS
mucor plumbeus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0913
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0913-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0913-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUCOR PLUMBEUS
mucor plumbeus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0914
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0914-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0914-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUCOR PLUMBEUS
mucor plumbeus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0915
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0915-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0915-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
NEUROSPORA INTERMEDIA
neurospora intermedia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0916
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0916-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0916-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
NEUROSPORA INTERMEDIA
neurospora intermedia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0917
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0917-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0917-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
NEUROSPORA INTERMEDIA
neurospora intermedia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0918
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0918-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
NEUROSPORA INTERMEDIA
neurospora intermedia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0919
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0919-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0919-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
NEUROSPORA INTERMEDIA
neurospora intermedia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0920
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0920-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0921
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0921-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0921-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0922
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0922-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0922-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0923
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0923-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0923-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0924
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0924-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0925
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0925-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0926
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0926-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0926-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0928
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0928-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0928-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0929
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0929-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0929-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0930
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0930-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0930-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0932
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0932-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0932-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0933
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0933-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0931
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0931-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHIZOPUS ARRHIZUS VAR ARRHIZUS
rhizopus batatas injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0934
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0934-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0934-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHIZOPUS ARRHIZUS VAR ARRHIZUS
rhizopus batatas injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0935
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0935-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0935-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHIZOPUS ARRHIZUS VAR ARRHIZUS
rhizopus batatas injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0936
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0936-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0936-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHIZOPUS ARRHIZUS VAR ARRHIZUS
rhizopus batatas injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0937
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0937-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0937-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0939
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0939-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0939-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0940
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0940-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0941
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0941-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0942
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0942-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0943
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0943-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0943-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0944
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0944-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
USTILAGO MAYDIS
corn smut injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0945
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0945-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0945-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
USTILAGO MAYDIS
corn smut injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0946
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0946-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
USTILAGO TRITICI
loose wheat smut injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0952
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO TRITICI (UNII: BV82OL2IZ8) (USTILAGO TRITICI - UNII:BV82OL2IZ8) USTILAGO TRITICI 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0952-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0952-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
STEMPHYLIUM SOLANI
stemphylium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0955
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0955-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0955-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
STEMPHYLIUM SOLANI
stemphylium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0956
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0956-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0956-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
STEMPHYLIUM SOLANI
stemphylium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0957
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0957-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0957-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
STEMPHYLIUM SOLANI
stemphylium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0958
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0958-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
STEMPHYLIUM SOLANI
stemphylium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0959
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0959-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0959-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0961
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0961-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0961-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0962
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0962-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0962-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0963
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0963-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0965
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0965-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0966
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0966-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0967
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0967-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0967-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SACCHAROMYCES CEREVISIAE
saccharomyces cerevisiae injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0968
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0968-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SACCHAROMYCES CEREVISIAE
saccharomyces cerevisiae injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0969
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0969-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACACIA
acacia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1000
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACACIA (UNII: 5C5403N26O) (ACACIA - UNII:5C5403N26O) ACACIA 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1000-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1000-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACACIA
acacia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1001
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACACIA (UNII: 5C5403N26O) (ACACIA - UNII:5C5403N26O) ACACIA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1001-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1001-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AILANTHUS ALTISSIMA POLLEN
ailanthus tree of heaven injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1004
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (AILANTHUS ALTISSIMA POLLEN - UNII:2A64U81OQ3) AILANTHUS ALTISSIMA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1004-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1004-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALNUS INCANA SSP RUGOSA POLLEN
alder white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1007
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (ALNUS INCANA SUBSP. RUGOSA POLLEN - UNII:605T96G8Y5) ALNUS INCANA SUBSP. RUGOSA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1007-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1007-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALNUS INCANA SSP RUGOSA POLLEN
alder white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1008
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (ALNUS INCANA SUBSP. RUGOSA POLLEN - UNII:605T96G8Y5) ALNUS INCANA SUBSP. RUGOSA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1008-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1008-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALNUS INCANA SSP RUGOSA POLLEN
alder white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1009
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (ALNUS INCANA SUBSP. RUGOSA POLLEN - UNII:605T96G8Y5) ALNUS INCANA SUBSP. RUGOSA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1009-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1009-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MEDICAGO SATIVA POLLEN
alfalfa injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1012
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY) (MEDICAGO SATIVA POLLEN - UNII:G515RAI9FY) MEDICAGO SATIVA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1012-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1012-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MEDICAGO SATIVA POLLEN
alfalfa injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1013
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY) (MEDICAGO SATIVA POLLEN - UNII:G515RAI9FY) MEDICAGO SATIVA POLLEN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1013-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS VELUTINA POLLEN
ash arizona injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1016
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1016-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS VELUTINA POLLEN
ash arizona injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1017
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1017-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1017-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3 NDC:0268-1017-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS VELUTINA POLLEN
ash arizona injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1018
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1018-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1021
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1021-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1022
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1022-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1022-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1023
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1023-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1023-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1024
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1024-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1024-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1025
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1025-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1026
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1026-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS TREMULOIDES POLLEN
aspen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1029
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA) (POPULUS TREMULOIDES POLLEN - UNII:928OC2TJDA) POPULUS TREMULOIDES POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1029-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1029-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS TREMULOIDES POLLEN
aspen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1030
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA) (POPULUS TREMULOIDES POLLEN - UNII:928OC2TJDA) POPULUS TREMULOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1030-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1030-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1033
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1033-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1034
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1034-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1034-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1035
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1035-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1035-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1036
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1036-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1036-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1037
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1037-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1038
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1038-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORELLA CERIFERA POLLEN
bayberry wax myrtle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1041
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89) MORELLA CERIFERA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1041-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1041-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORELLA CERIFERA POLLEN
bayberry wax myrtle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1042
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89) MORELLA CERIFERA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1042-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1042-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORELLA CERIFERA POLLEN
bayberry wax myrtle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1043
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89) MORELLA CERIFERA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1043-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FAGUS GRANDIFOLIA POLLEN
beech injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1046
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1046-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1046-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FAGUS GRANDIFOLIA POLLEN
beech injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1047
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1047-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1047-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FAGUS GRANDIFOLIA POLLEN
beech injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1048
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1048-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1048-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FAGUS GRANDIFOLIA POLLEN
beech injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1049
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1049-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1056
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1056-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1056-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1057
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1057-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1057-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1058
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1058-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1059
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 50000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1059-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA NIGRA POLLEN
birch river red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1062
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1062-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1062-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA NIGRA POLLEN
birch river red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1063
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1063-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1063-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA NIGRA POLLEN
birch river red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1064
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1064-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA NIGRA POLLEN
birch river red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1065
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1065-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA NIGRA POLLEN
birch river red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1066
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1066-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1066-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1069
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1069-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1069-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1070
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1070-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1070-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1071
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1071-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1072
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1072-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1073
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1073-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1073-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POA ANNUA POLLEN
bluegrass annual injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1076
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA ANNUA POLLEN (UNII: 7U437HHU5C) (POA ANNUA POLLEN - UNII:7U437HHU5C) POA ANNUA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1076-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POA ANNUA POLLEN
bluegrass annual injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1077
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA ANNUA POLLEN (UNII: 7U437HHU5C) (POA ANNUA POLLEN - UNII:7U437HHU5C) POA ANNUA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1077-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER NEGUNDO POLLEN
box elder ash leaf maple injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1080
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1080-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1080-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER NEGUNDO POLLEN
box elder ash leaf maple injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1081
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1081-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1081-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER NEGUNDO POLLEN
box elder ash leaf maple injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1082
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1082-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1082-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER NEGUNDO POLLEN
box elder ash leaf maple injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1083
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1083-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BROMUS INERMIS POLLEN
brome grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1086
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1086-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1086-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BROMUS INERMIS POLLEN
brome grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1087
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1087-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1087-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BROMUS INERMIS POLLEN
brome grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1089
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1089-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS PALMERI POLLEN
carelessweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1092
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1092-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1092-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS PALMERI POLLEN
carelessweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1093
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1093-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1093-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS PALMERI POLLEN
carelessweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1094
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1094-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS ASHEI POLLEN
cedar mountain injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1097
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1097-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1097-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS ASHEI POLLEN
cedar mountain injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1098
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1098-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1098-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS ASHEI POLLEN
cedar mountain injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1099
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1099-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1099-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1102
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1102-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1102-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1103
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1103-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1103-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1104
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1104-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1105
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1105-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1106
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1106-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1106-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1107
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1107-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1110
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1110-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1110-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1111
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1111-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1111-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1112
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1112-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1112-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1113
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1113-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1114
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1114-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1115
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1115-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1116
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1116-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1117
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1117-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ZEA MAYS POLLEN
corn pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1120
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1120-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1120-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ZEA MAYS POLLEN
corn pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1121
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1121-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1121-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ZEA MAYS POLLEN
corn pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1122
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1122-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ZEA MAYS POLLEN
corn pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1123
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1123-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1126
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1126-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1126-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1127
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1127-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1127-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1128
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1128-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1128-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1129
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1129-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1129-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1130
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1130-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS FREMONTII POLLEN
cottonwood fremont injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1133
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (POPULUS FREMONTII POLLEN - UNII:426RHB4302) POPULUS FREMONTII POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1133-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS FREMONTII POLLEN
cottonwood fremont injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1134
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (POPULUS FREMONTII POLLEN - UNII:426RHB4302) POPULUS FREMONTII POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1134-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS FREMONTII POLLEN
cottonwood fremont injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1135
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (POPULUS FREMONTII POLLEN - UNII:426RHB4302) POPULUS FREMONTII POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1135-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES SSP MONILIFERA POLLEN
cottonwood western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1138
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441) (POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - UNII:5928LJ1441) POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1138-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES SSP MONILIFERA POLLEN
cottonwood western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1139
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441) (POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - UNII:5928LJ1441) POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1139-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1139-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CUPRESSUS ARIZONICA POLLEN
cypress arizona injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1142
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (CUPRESSUS ARIZONICA POLLEN - UNII:232DMH0XVF) CUPRESSUS ARIZONICA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1142-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CUPRESSUS ARIZONICA POLLEN
cypress arizona injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1143
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (CUPRESSUS ARIZONICA POLLEN - UNII:232DMH0XVF) CUPRESSUS ARIZONICA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1143-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1143-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TAXODIUM DISTICHUM POLLEN
cypress bald injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1146
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1146-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1146-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TAXODIUM DISTICHUM POLLEN
cypress bald injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1147
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1147-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1147-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TAXODIUM DISTICHUM POLLEN
cypress bald injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1148
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1148-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1151
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1151-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1151-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1152
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1152-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1152-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1153
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1153-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1153-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1154
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1154-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1155
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1155-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1155-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1156
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 60000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1156-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX CRISPUS POLLEN
dock yellow injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1159
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1159-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1159-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX CRISPUS POLLEN
dock yellow injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1160
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1160-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1160-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX CRISPUS POLLEN
dock yellow injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1161
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1161-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1161-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUPATORIUM CAPILLIFOLIUM POLLEN
dog fennel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1164
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (EUPATORIUM CAPILLIFOLIUM POLLEN - UNII:B67NF86HF0) EUPATORIUM CAPILLIFOLIUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1164-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1164-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUPATORIUM CAPILLIFOLIUM POLLEN
dog fennel non stock injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1165
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (EUPATORIUM CAPILLIFOLIUM POLLEN - UNII:B67NF86HF0) EUPATORIUM CAPILLIFOLIUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1165-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1165-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1168
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1168-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1168-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1169
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1169-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1169-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1170
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1170-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1170-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1171
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1171-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1172
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1172-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1607
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1607-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1174
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1174-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS CRASSIFOLIA POLLEN
elm cedar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1177
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I) (ULMUS CRASSIFOLIA POLLEN - UNII:G82398SD3I) ULMUS CRASSIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1177-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS CRASSIFOLIA POLLEN
elm cedar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1178
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I) (ULMUS CRASSIFOLIA POLLEN - UNII:G82398SD3I) ULMUS CRASSIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1178-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS PUMILA POLLEN
elm chinese injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1181
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS PUMILA POLLEN (UNII: 030R993R8E) (ULMUS PUMILA POLLEN - UNII:030R993R8E) ULMUS PUMILA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1181-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1181-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS PUMILA POLLEN
elm chinese injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1182
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS PUMILA POLLEN (UNII: 030R993R8E) (ULMUS PUMILA POLLEN - UNII:030R993R8E) ULMUS PUMILA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1182-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1182-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUCALYPTUS GLOBULUS POLLEN
eucalyptus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1185
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1185-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUCALYPTUS GLOBULUS POLLEN
eucalyptus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1186
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1186-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1186-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUCALYPTUS GLOBULUS POLLEN
eucalyptus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1187
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1187-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUCALYPTUS GLOBULUS POLLEN
eucalyptus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1188
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1188-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1191
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1191-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1192
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1192-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1192-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1193
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1193-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1608
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1608-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1195
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1195-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1195-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CELTIS OCCIDENTALIS POLLEN
hackberry injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1198
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1198-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1198-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CELTIS OCCIDENTALIS POLLEN
hackberry injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1199
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1199-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1199-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CELTIS OCCIDENTALIS POLLEN
hackberry injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1200
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1200-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CORYLUS AMERICANA POLLEN
hazelnut pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1203
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1203-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CORYLUS AMERICANA POLLEN
hazelnut pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1204
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1204-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1204-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CORYLUS AMERICANA POLLEN
hazelnut pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1205
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1205-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CORYLUS AMERICANA POLLEN
hazelnut pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1206
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1206-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1214
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1214-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1214-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1215
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1215-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1215-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1216
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1216-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1216-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1217
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1217-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1218
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1218-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1219
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1219-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1220
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1220-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS CALIFORNICA POLLEN
juniper western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1223
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1223-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS CALIFORNICA POLLEN
juniper western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1224
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1224-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1224-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS CALIFORNICA POLLEN
juniper western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1225
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1225-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1225-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
KOCHIA SCOPARIA POLLEN
kochia firebush injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1232
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1232-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1232-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
KOCHIA SCOPARIA POLLEN
kochia firebush injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1233
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1233-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1233-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
KOCHIA SCOPARIA POLLEN
kochia firebush injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1234
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1234-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1234-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
KOCHIA SCOPARIA POLLEN
kochia firebush injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1235
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1235-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1238
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1238-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1238-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1239
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1239-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1239-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1240
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1240-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1240-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1241
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1241-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1242
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1242-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ROBINIA PSEUDOACACIA POLLEN
locust black non stock injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1245
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROBINIA PSEUDOACACIA POLLEN (UNII: 8003NOJ82F) (ROBINIA PSEUDOACACIA POLLEN - UNII:8003NOJ82F) ROBINIA PSEUDOACACIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1245-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER RUBRUM POLLEN
maple red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1248
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1248-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1248-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER RUBRUM POLLEN
maple red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1249
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1249-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1249-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER SACCHARUM POLLEN
maple sugar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1252
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1252-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1252-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER SACCHARUM POLLEN
maple sugar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1253
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1253-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1253-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER SACCHARUM POLLEN
maple sugar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1254
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1254-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1254-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER SACCHARUM POLLEN
maple sugar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1255
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1255-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA XANTHIFOLIA POLLEN
marshelder burweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1258
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1258-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1258-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA XANTHIFOLIA POLLEN
marshelder burweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1259
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1259-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1259-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA XANTHIFOLIA POLLEN
marshelder burweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1260
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1260-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1260-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA ANNUA VAR ANNUA POLLEN
marshelder rough injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1263
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1263-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1263-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA ANNUA VAR ANNUA POLLEN
marshelder rough injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1264
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1264-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1264-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA ANNUA VAR ANNUA POLLEN
marshelder rough injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1265
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1265-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1265-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA ANNUA VAR ANNUA POLLEN
marshelder rough injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1266
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1266-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MELALEUCA QUINQUENERVIA POLLEN
melaleuca pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1273
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1273-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1273-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MELALEUCA QUINQUENERVIA POLLEN
melaleuca pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1274
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1274-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1274-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MELALEUCA QUINQUENERVIA POLLEN
melaleuca pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1275
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1275-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MELALEUCA QUINQUENERVIA POLLEN
melaleuca pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1276
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1276-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1276-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PROSOPIS JULIFLORA POLLEN
mesquite injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1279
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1279-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1279-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PROSOPIS JULIFLORA POLLEN
mesquite injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1280
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1280-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1280-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PROSOPIS JULIFLORA POLLEN
mesquite injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1281
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1281-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM AMBROSIOIDES POLLEN
mexican tea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1284
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1284-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1284-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
CHENOPODIUM AMBROSIOIDES POLLEN
mexican tea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1285
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1285-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1285-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
CHENOPODIUM AMBROSIOIDES POLLEN
mexican tea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1286
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1286-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1286-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
ARTEMISIA VULGARIS POLLEN
mugwort common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1297
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1297-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1297-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA VULGARIS POLLEN
mugwort common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1298
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1298-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1298-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA VULGARIS POLLEN
mugwort common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1299
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1299-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1299-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA VULGARIS POLLEN
mugwort common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1300
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1300-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1300-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA VULGARIS POLLEN
mugwort common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1301
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1301-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS RUBRA POLLEN
mulberry red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1304
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1304-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1304-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS RUBRA POLLEN
mulberry red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1305
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1305-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1305-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS RUBRA POLLEN
mulberry red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1306
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1306-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1306-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS RUBRA POLLEN
mulberry red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1307
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1307-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS ALBA POLLEN
mulberry white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1310
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1310-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1310-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS ALBA POLLEN
mulberry white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1311
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1311-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1311-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS AGRIFOLIA POLLEN
oak california live coast injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1314
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (QUERCUS AGRIFOLIA POLLEN - UNII:VOT5MA71M7) QUERCUS AGRIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1314-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1314-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS AGRIFOLIA POLLEN
oak california live coast injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1315
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (QUERCUS AGRIFOLIA POLLEN - UNII:VOT5MA71M7) QUERCUS AGRIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1315-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1315-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS RUBRA POLLEN
oak red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1318
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1318-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1318-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS RUBRA POLLEN
oak red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1319
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1319-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1319-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS VIRGINIANA POLLEN
oak virginia live injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1322
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1322-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1322-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS VIRGINIANA POLLEN
oak virginia live injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1323
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1323-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1323-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS VIRGINIANA POLLEN
oak virginia live injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1324
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1324-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1327
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1327-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1327-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1328
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1328-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1328-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1329
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1329-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1329-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1330
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1330-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1613
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1613-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1332
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 50000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1332-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1333
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1333-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oat wild pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1336
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1336-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1336-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
OLEA EUROPAEA POLLEN
olive pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1339
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627) OLEA EUROPAEA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1339-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1339-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
OLEA EUROPAEA POLLEN
olive pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1340
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627) OLEA EUROPAEA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1340-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1340-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SYAGRUS ROMANZOFFIANA POLLEN
palm queen coco palm injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1347
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (SYAGRUS ROMANZOFFIANA POLLEN - UNII:84ZOM591BB) SYAGRUS ROMANZOFFIANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1347-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1347-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SYAGRUS ROMANZOFFIANA POLLEN
palm queen coco palm injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1348
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (SYAGRUS ROMANZOFFIANA POLLEN - UNII:84ZOM591BB) SYAGRUS ROMANZOFFIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1348-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1348-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1354
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1354-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1354-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1355
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1355-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1355-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1614
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1614-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1358
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1358-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SCHINUS MOLLE POLLEN
pepper tree california injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1361
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1) (SCHINUS MOLLE POLLEN - UNII:M0G28FH9K1) SCHINUS MOLLE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1361-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1361-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1364
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1364-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1364-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1365
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1365-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1365-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1366
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1366-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1366-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1367
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1367-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1368
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1368-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS SPINOSUS POLLEN
pigweed spiny injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1371
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1371-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1371-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS SPINOSUS POLLEN
pigweed spiny injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1372
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1372-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1372-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS SPINOSUS POLLEN
pigweed spiny injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1373
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1373-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CASUARINA EQUISETIFOLIA POLLEN
pine australian beefwood injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1376
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1376-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1376-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CASUARINA EQUISETIFOLIA POLLEN
pine australian beefwood injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1377
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1377-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1377-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CASUARINA EQUISETIFOLIA POLLEN
pine australian beefwood injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1378
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1378-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CASUARINA EQUISETIFOLIA POLLEN
pine australian beefwood injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1379
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 50000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1379-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1379-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS STROBUS POLLEN
pine white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1382
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1382-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1382-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS STROBUS POLLEN
pine white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1383
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1383-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1383-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS STROBUS POLLEN
pine white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1384
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1384-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS STROBUS POLLEN
pine white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1385
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1385-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS STROBUS POLLEN
pine white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1386
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1386-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS ECHINATA POLLEN
pine yellow injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1389
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS ECHINATA POLLEN (UNII: 96LRW14765) (PINUS ECHINATA POLLEN - UNII:96LRW14765) PINUS ECHINATA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1389-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1389-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS ECHINATA POLLEN
pine yellow injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1390
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS ECHINATA POLLEN (UNII: 96LRW14765) (PINUS ECHINATA POLLEN - UNII:96LRW14765) PINUS ECHINATA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1390-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1390-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1394
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1394-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1394-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1395
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1395-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1395-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1396
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1396-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1397
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1397-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1397-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1616
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1616-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1399
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1399-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1399-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1400
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1400-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1400-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1401
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1401-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1402
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1402-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS ALBA POLLEN
poplar white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1405
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1405-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1405-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS ALBA POLLEN
poplar white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1406
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1406-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1406-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS ALBA POLLEN
poplar white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1407
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1407-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1407-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS ALBA POLLEN
poplar white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1408
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1408-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS ALBA POLLEN
poplar white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1409
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1409-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIGUSTRUM VULGARE POLLEN
privet injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1412
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1412-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1412-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIGUSTRUM VULGARE POLLEN
privet injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1413
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1413-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1413-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIGUSTRUM VULGARE POLLEN
privet injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1414
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1414-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIGUSTRUM VULGARE POLLEN
privet injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1415
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1415-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 08/01/2017
ELYMUS REPENS POLLEN
quack grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1418
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1418-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1418-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ELYMUS REPENS POLLEN
quack grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1419
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1419-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ELYMUS REPENS POLLEN
quack grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1420
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1420-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ACANTHICARPA POLLEN
ragweed false bur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1423
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y) (AMBROSIA ACANTHICARPA POLLEN - UNII:U2AI3H2J5Y) AMBROSIA ACANTHICARPA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1423-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1423-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ACANTHICARPA POLLEN
ragweed false bur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1424
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y) (AMBROSIA ACANTHICARPA POLLEN - UNII:U2AI3H2J5Y) AMBROSIA ACANTHICARPA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1424-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1424-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TENUIFOLIA POLLEN
ragweed slender injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1431
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TENUIFOLIA POLLEN (UNII: 57W5SO585B) (AMBROSIA TENUIFOLIA POLLEN - UNII:57W5SO585B) AMBROSIA TENUIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1431-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TENUIFOLIA POLLEN
ragweed slender injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1432
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TENUIFOLIA POLLEN (UNII: 57W5SO585B) (AMBROSIA TENUIFOLIA POLLEN - UNII:57W5SO585B) AMBROSIA TENUIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1432-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA BIDENTATA POLLEN
ragweed southern injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1435
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (AMBROSIA BIDENTATA POLLEN - UNII:M3S672G75O) AMBROSIA BIDENTATA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1435-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1435-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA BIDENTATA POLLEN
ragweed southern injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1436
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (AMBROSIA BIDENTATA POLLEN - UNII:M3S672G75O) AMBROSIA BIDENTATA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1436-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1436-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ARTEMISIIFOLIA POLLEN
ragweed short injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1531
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1531-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1531-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ARTEMISIIFOLIA POLLEN
ragweed short injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1532
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1532-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1532-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ARTEMISIIFOLIA POLLEN
ragweed short injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1533
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1533-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ARTEMISIIFOLIA POLLEN
ragweed short injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1534
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1534-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1534-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TRIFIDA POLLEN
ragweed tall giant injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1439
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1439-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1439-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TRIFIDA POLLEN
ragweed tall giant injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1440
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1440-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1440-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TRIFIDA POLLEN
ragweed tall giant injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1441
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1441-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TRIFIDA POLLEN
ragweed tall giant injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1442
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1442-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA PSILOSTACHYA POLLEN
ragweed western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1445
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1445-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1445-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA PSILOSTACHYA POLLEN
ragweed western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1446
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1446-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1446-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALSOLA KALI POLLEN
russian thistle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1453
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1453-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1453-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALSOLA KALI POLLEN
russian thistle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1454
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1454-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1454-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALSOLA KALI POLLEN
russian thistle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1455
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1455-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1455-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALSOLA KALI POLLEN
russian thistle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1456
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1456-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALSOLA KALI POLLEN
russian thistle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1457
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1457-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LOLIUM PERENNE SSP MULTIFLORUM POLLEN
rye grass italian injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1460
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOLIUM MULTIFLORUM POLLEN (UNII: VJI0WKK736) (LOLIUM MULTIFLORUM POLLEN - UNII:VJI0WKK736) LOLIUM MULTIFLORUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1460-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA FRIGIDA POLLEN
sage prairie injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1467
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA FRIGIDA POLLEN (UNII: 5AN5LR8L3F) (ARTEMISIA FRIGIDA POLLEN - UNII:5AN5LR8L3F) ARTEMISIA FRIGIDA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1467-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA FRIGIDA POLLEN
sage prairie injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1468
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA FRIGIDA POLLEN (UNII: 5AN5LR8L3F) (ARTEMISIA FRIGIDA POLLEN - UNII:5AN5LR8L3F) ARTEMISIA FRIGIDA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1468-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1468-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA TRIDENTATA POLLEN
sagebrush common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1471
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1471-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1471-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA TRIDENTATA POLLEN
sagebrush common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1472
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1472-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1472-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA TRIDENTATA POLLEN
sagebrush common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1473
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1473-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
DISTICHLIS SPICATA POLLEN
salt grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1476
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV) (DISTICHLIS SPICATA POLLEN - UNII:GOA51670YV) DISTICHLIS SPICATA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1476-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1476-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
DISTICHLIS SPICATA POLLEN
salt grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1477
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV) (DISTICHLIS SPICATA POLLEN - UNII:GOA51670YV) DISTICHLIS SPICATA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1477-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1477-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ATRIPLEX WRIGHTII POLLEN
saltbush annual atriplex injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1480
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O) (ATRIPLEX WRIGHTII POLLEN - UNII:YB1308W43O) ATRIPLEX WRIGHTII POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1480-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1480-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ATRIPLEX WRIGHTII POLLEN
saltbush annual atriplex injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1481
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O) (ATRIPLEX WRIGHTII POLLEN - UNII:YB1308W43O) ATRIPLEX WRIGHTII POLLEN 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1481-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1481-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1493
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1493-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1493-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1494
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1494-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1494-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1495
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1495-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1496
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1496-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1497
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1497-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1498
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1498-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLATANUS OCCIDENTALIS POLLEN
sycamore american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1501
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1501-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1501-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLATANUS OCCIDENTALIS POLLEN
sycamore american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1502
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1502-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1502-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLATANUS OCCIDENTALIS POLLEN
sycamore american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1503
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1503-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1503-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLATANUS OCCIDENTALIS POLLEN
sycamore american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1504
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1504-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLATANUS OCCIDENTALIS POLLEN
sycamore american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1505
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1505-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HOLCUS LANATUS POLLEN
velvet grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1510
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01) HOLCUS LANATUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1510-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1510-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HOLCUS LANATUS POLLEN
velvet grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1511
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01) HOLCUS LANATUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1511-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS NIGRA POLLEN
walnut black pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1512
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1512-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1512-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS NIGRA POLLEN
walnut black pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1513
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1513-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1513-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS NIGRA POLLEN
walnut black pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1514
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1514-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1514-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS NIGRA POLLEN
walnut california black pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1515
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1515-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS REGIA POLLEN
walnut english pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1516
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS REGIA POLLEN (UNII: ARW43087I1) (JUGLANS REGIA POLLEN - UNII:ARW43087I1) JUGLANS REGIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1516-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS REGIA POLLEN
walnut english pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1517
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS REGIA POLLEN (UNII: ARW43087I1) (JUGLANS REGIA POLLEN - UNII:ARW43087I1) JUGLANS REGIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1517-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1517-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS TUBERCULATUS POLLEN
water hemp injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1518
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1518-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1518-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS TUBERCULATUS POLLEN
water hemp injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1519
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1519-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1519-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS TUBERCULATUS POLLEN
water hemp injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1520
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1520-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1520-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS TUBERCULATUS POLLEN
water hemp injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1521
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1521-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRITICUM AESTIVUM POLLEN
wheat pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1522
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (TRITICUM AESTIVUM POLLEN - UNII:F1KAH8374D) TRITICUM AESTIVUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1522-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1522-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRITICUM AESTIVUM POLLEN
wheat pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1523
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (TRITICUM AESTIVUM POLLEN - UNII:F1KAH8374D) TRITICUM AESTIVUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1523-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1523-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1524
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1524-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1524-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1525
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1525-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1525-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1526
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1526-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1526-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1527
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1527-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1527-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1528
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1528-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1529
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1529-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA ANNUA POLLEN
wormwood common annual injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1530
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1530-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1530-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1601
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1601-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RABBIT
rabbit injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0652
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0652-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS ASHEI POLLEN
cedar mountain injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1602
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1602-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1603
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1603-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1604
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1604-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1605
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1605-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1606
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1606-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1173
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1173-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1194
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1194-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS CALIFORNICA POLLEN
juniper western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1609
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1609-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1610
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1610-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM AMBROSIOIDES POLLEN
mexican tea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1611
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1611-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1611-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
QUERCUS AGRIFOLIA POLLEN
oak california live coast injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1612
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (QUERCUS AGRIFOLIA POLLEN - UNII:VOT5MA71M7) QUERCUS AGRIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1612-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1331
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1331-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1356
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1356-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1357
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1357-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1398
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1398-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PYRETHRUM CINERARIIFOLIUM
pyrethrum cinerariifolium injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0645
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TANACETUM CINERARIIFOLIUM FLOWER (UNII: CGF76TP7X6) (TANACETUM CINERARIIFOLIUM FLOWER - UNII:CGF76TP7X6) TANACETUM CINERARIIFOLIUM FLOWER 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0645-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PYRETHRUM CINERARIIFOLIUM
pyrethrum cinerariifolium injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0646
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TANACETUM CINERARIIFOLIUM FLOWER (UNII: CGF76TP7X6) (TANACETUM CINERARIIFOLIUM FLOWER - UNII:CGF76TP7X6) TANACETUM CINERARIIFOLIUM FLOWER 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0646-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 02/23/1998
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1615
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1615-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 02/23/1998
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0001
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0001-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0002
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0002-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0003
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0003-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0004
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0004-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0004-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0005
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0005-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0005-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0006
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0006-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0007
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0007-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0007-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0008
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0008-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0009
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0009-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0009-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0010
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0010-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0011
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0011-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0011-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0012
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0012-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0012-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0013
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0013-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0013-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
BOS TAURUS SKIN
cattle epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0603
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0603-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0603-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOS TAURUS SKIN
cattle epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0604
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0604-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOS TAURUS SKIN
cattle epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0605
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0605-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOS TAURUS SKIN
cattle epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0606
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0606-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COTTON FIBER
cotton linters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0609
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COTTON FIBER (UNII: 70LDW53ROO) (COTTON FIBER - UNII:70LDW53ROO) COTTON FIBER 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0609-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0609-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COTTON SEED
cottonseed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0612
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COTTON SEED (UNII: DI0ZRJ0MXN) (COTTON SEED - UNII:DI0ZRJ0MXN) COTTON SEED 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0612-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0615
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0615-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0615-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0616
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0616-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0617
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0617-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0618
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0618-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0618-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0619
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0619-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0619-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0620
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0620-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0620-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0621
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.05 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0621-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0621-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0622
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0622-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0623
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0623-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0624
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0624-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0624-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0625
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0625-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0626
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0626-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0626-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0627
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0627-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1600
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1600-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CAVIA PORCELLUS SKIN
guinea pig epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0653
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0653-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0653-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CAVIA PORCELLUS SKIN
guinea pig epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0654
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0654-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CAVIA PORCELLUS SKIN
guinea pig epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0655
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0655-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0655-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0628
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0628-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0628-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3 NDC:0268-0628-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0629
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0629-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0629-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
Labeler - ALK-Abello, Inc. (809998847)

Revised: 8/2017 ALK-Abello, Inc.

 

DIRECTIONS FOR USE OF
THERAPEUTIC
ALLERGENIC EXTRACTS

Warning 

This product is intended for use by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis or for use under the guidance of an allergy specialist.

Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact he physician's office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals, these reactions may rarely result in death. Patients should be observed for 20 to 30 minutes following treatment, and emergency measures, as well as personnel trained in their use, should be immediately available in the event of a life-threatening reaction. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk. Adverse events are to be reported to Med Watch (1-800 FDA-1088), Adverse Experience Reporting , Food and Drug Administration, , Rockville, MD 20852-9787.

This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for the treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously.

Refer to WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections below.

Description 

Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. Inactive ingredients in mold extracts may include residual: Potassium Phosphate, Citrate, Magnesium Phosphate and Calcium Carbonate from growth media. These products are compounded and diluted on a w/v or PNU basis.

Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety.

Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously.

Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.

Clinical Pharmacology 

The treatment consists of the subcutaneous injection of gradually increasing doses of the allergens to which the patient is allergic. It has been demonstrated that this method of treatment induces an increased tolerance to the allergens responsible for the symptoms on subsequent exposure. The exact relationships between allergen, skin-sensitizing antibody (IgE) and the blocking antibody (IgG) have not been precisely established. Clinically confirmed immunological studies have adduced evidence of the efficacy of hyposensitization therapy.

Numerous controlled studies have demonstrated the clinical efficacy of immunotherapy with cat, dust mites and some pollen extracts. Nevertheless, responses are variable, and in a few studies patients reported no appreciable benefit.

Extracts containing Short Ragweed pollen bear a labeled potency declaration in terms of Antigen E content. Numerous studies have confirmed Antigen E (AgE) as the major antigen associated with Short Ragweed pollinosis.1 Therefore, it is essential that the physician be aware of AgE content of allergenic extract administered for hyposensitization therapy.

Some studies have indicated that for most patients a cumulative Antigen E dosage of less than 0.1 units is not immunizing (sufficient to stimulate specific IgG antibodies.)2 This, however, does not suggest that 0.1 unit is a maximum tolerated dose. Most moderately sensitive patients may tolerate a dosage of ten to fifty times greater. If results with this product are unsatisfactory with exquisitely sensitive patients who cannot tolerate an immunizing dose, the physician should consider alternative therapy.

One well-controlled study demonstrated that standard immunotherapy (gradually increasing doses of antigen given subcutaneously to a maximum tolerated peak dose), using crude ragweed extract of known Antigen E potency, was significantly superior to placebo and low dose immunotherapy ( 0.1 units AgE cumulative dose) in amelioration of symptoms associated with ragweed hay fever. These patients received a cumulative dose of 18-350 units Antigen E (median = 84.9 units). The maximum single dose ranged from 3.7 to 46.8 units (median = 11.1 units) prior to the ragweed hay fever season10.

Patients for this study were sensitive to Ragweed Antigen E, as determined by intradermal skin testing at a dose 0.01 units AgE/mL. A series of 24 weekly injections were administered. Forty-seven percent of the patients experienced at least one systemic reaction with an average of 1.2 systemic reactions per patient. None of the patients were able to achieve the expected maximum dose (90 units of Antigen E) in the 24 weekly injection dosage schedule.

Indications And Usage 

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal dander, various other inhalants, and in situations where the offending allergen cannot be avoided.

Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.

Contraindications 

A patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms, IgE antibodies, positive skin tests, or properly controlled challenge testing. In most cases, immunotherapy is not indicated for those allergens that can be eliminated or minimized by environmental control.

Patients on beta-blockers are not candidates for immunotherapy, as they can be non-responsive to beta-agonists that may be required to reverse a systemic reaction (also see WARNINGS AND ADVERSE REACTIONS).

In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indication of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself.

Also, there is some evidence, although inconclusive, that routine immunizations may exacerbate autoimmune diseases.3, 4, 5 Hyposensitization should be given cautiously to patients with this predisposition. Patients with severe cardiorespiratory symptoms are at an additional risk during a systemic reaction. The physician must weigh risk to benefit in these cases.

Warnings 

Patients should always be observed for at least 20 - 30 minutes after any injection. In the event of a marked systemic reaction, application of a tourniquet above the injection site and administration of 0.2 mL to 1 mL (0.01 mg/kg) of Epinephrine Injection (1:1,000) is recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released at 15 minute intervals. Patients under treatment with beta-blockers may be refractory to the usual dose of epinephrine.

Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In cases of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reaction unresponsive to the above may require cardiopulmonary resuscitation.

DO NOT GIVE INTRAVENOUSLY

After inserting the needle, but before injecting the dose, pull plunger of the syringe slightly. If blood returns in the syringe, discard the syringe and contents and repeat injection at another site.

Bulk concentrated extracts must be diluted for initial therapy.

Withhold allergenic extracts temporarily or reduce the dose in patients with any one of the following conditions:

- Severe rhinitis or asthma symptoms;

- Infection or flu accompanied by fever;

- Exposure to excessive amounts of clinically relevant allergen prior to therapy.

Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk. See PRECAUTIONS AND ADVERSE REACTIONS.

TRANSFER OF PATIENTS

From pyridine extracted alum complexed allergenic extracts to aqueous extracts and glycerinated: In order to avoid untoward reaction, it is recommended that therapy be initiated as though the patients were previously untreated. The first dose should be related to the patient's sensitivity, determined by history and confirmed by skin testing.

From unstandardized aqueous extracts to standardized aqueous extracts and glycerinated: The physician should establish the potency relationship, perhaps by comparative skin testing at equal concentration, prior to injecting the first standardized dose.

From aqueous alum precipitated or modified extracts to aqueous extracts and glycerinated: Since this subject has not been studied, it is recommended that therapy be initiated as if the patient were not previously treated.

Precautions 

INFORMATION TO PATIENTS:

Patients should be instructed to describe any active allergic symptoms such as rhinitis, wheezing, dyspnea, etc. prior to injection including any late reactions from previous administration. Patients should be instructed to remain in the office for 20 to 30 minutes after injection to monitor for adverse reactions. Also, see ADVERSE REACTIONS and WARNINGS Sections.

If the protective action of allergenic extract injections is considered essential for the patient's welfare, appropriate symptomatic therapy with antihistaminic, adrenergic or other drugs might be needed either prior to or in conjunction with the allergenic extract injections.

GENERAL:

  1. Objective assessment of pulmonary function such as Peak Expiratory Flow Rate (PEFR) before allergen administration may be useful in unstable asthmatic to reduce the chances of exacerbation of the patient's asthma.
  2. Store allergenic extracts between 2o to 8oC at all times, even during use.
  3. Injections are to be given subcutaneously with the usual sterile precautions using a tuberculin syringe.
  4. Care must be taken to avoid injecting into a blood vessel. Pull gently on syringe plunger to determine if a blood vessel has been entered (See WARNINGS).
  5. Allergenic extracts slowly become less potent with age. During the course of treatment, it may be necessary to continue therapy with a vial of extract bearing a later expiration date. The initial dose of the extract bearing the later expiration date should be lowered to a safe, non-reaction eliciting level which can be confirmed by comparative skin testing using end-point titration.
  6. Use standard aseptic precautions when making dilutions. The first dose of the new extract should be reduced to at least 25% of the amount of the dosage from the previous extract.
  7. Extracts in 50% glycerin can cause discomfort at the site of the injection.

PREGNANCY - CATEGORY C:

Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Controlled studies of hyposensitization with moderate to high doses of allergenic extracts during conception and all trimesters of pregnancy have failed to demonstrate any risk to the fetus or to the mother. However, on the basis of histamine's known ability to contract the uterine muscle, the release of significant amounts of histamine from allergen exposure or hyposensitization overdose should be avoided on theoretical grounds. Therefore, allergenic extracts should be used cautiously in a pregnant woman and only if clearly needed.

PEDIATRIC USE:

Children can receive the same dose as adults, however, to minimize the discomfort associated with dose volume it may be advisable to reduce the volume of the dose by one-half and administer the injection at two different sites.

NURSING MOTHERS:

It is not known if allergens administered subcutaneously appear in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:

Studies in animals have not been performed.

DRUG INTERACTIONS:

Drugs can interfere with the performance of skin tests.6

Antihistamines: Response to mediator (histamine) released by allergens is suppressed by antihistamines. The length of suppression varies and is dependent on individual patient, type of antihistamine and length of time the patient has been on antihistamines. The duration of this suppression may be as little as 24 hours (chlorpheniramine), and can be as long as 40 days (astemizole).

Tricyclic Antidepressants: These exert a potent and sustained decrease of skin reactivity to histamine which may last for a few weeks.

Beta2 Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal.

Dopamine: Intravenous infusion of dopamine may inhibit skin test responses.

Beta Blocking Agents: Propranolol can significantly increase skin test reactivity (See WARNINGS).

Other Drugs: Short acting steroids, inhaled beta2 agonists, theophylline and cromolyn do not seem to affect skin test response.

Adverse Reactions 

Anaphylaxis and deaths following the injection of mite and other extracts have been reported by The British Committee on Safety in Medicine.7 Fatalities from immunotherapy in the United States since 1945 have been extensively reviewed by Lockey, R F, et al8 and more recently by Reid M J et al9.

With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.

Local: Reactions at the site of injection may be immediate or delayed. Immediate wheal and erythema reactions are ordinarily of little consequence; but if very large, may be the first manifestation of a systemic reaction. If large local reactions occur, the patient should be observed for systemic symptoms for which treatment is outlined below.

Delayed reactions start several hours after injection with local edema, erythema, itching or pain. They are usually at their peak at 24 hours and usually require no treatment. Antihistamine drugs may be administered orally.

The next therapeutic dose should be reduced to the dose which did not elicit a reaction, and subsequent doses increased more slowly; i.e., use of intermediate dilutions.

Systemic: Systemic reactions are characterized by one or more of the following symptoms: Sneezing, mild to severe generalized urticaria, itching other than at the injection site, extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, tachycardia, lacrimation, marked perspiration, cough, hypotension, syncope and upper airway obstruction. Symptoms may progress to shock and death. Patients should always be observed for at least 20 to 30 minutes after any injection. Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalational bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. Severe airway obstruction, unresponsive to bronchodilator, may require tracheal intubation and use of oxygen. In the event of a marked systemic reaction, application of a tourniquet above the injection site and the administration of 0.2 mL to 1 mL of Epinephrine Injection (1:1,000) are recommended. Maximal recommended dose for children under 2 years of age is 0.3 mL. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet should not be left in place without loosening for 90 seconds for every 15 minutes.

The next therapeutic injection of extract should be reduced to the dose which did not elicit a reaction, and subsequent doses increased more slowly; i.e., use of intermediate dilutions.

Overdosage 

Signs and symptoms of overdose are typically local and systemic reactions. For a description and management of overdose reactions, refer to "Adverse Reaction" section above.

Dosage And Administration 

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

When diluting bulk extracts, use of Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA (albumin saline) is recommended. Dilutions should be made with sterile disposable syringes using aseptic technique. Commonly, 10 fold dilutions are used to achieve a desired concentration for initiation and continuation of immunotherapy. For example, transferring 0.5 mL of a 10,000 PNU/mL extract into 4.5 mL of diluent will yield 5 mL of extract at 1,000 PNU/mL. For weight volume products, a 1:100 w/v dilution may be prepared from a 1:10 w/v by transferring 0.5 mL of the 1:10 w/v to 4.5 mL of diluent. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration.

Starting dose for immunotherapy is related directly to a patient's sensitivity as determined by carefully executed skin testing. Degree of sensitivity can be established by determination of D5011. A general rule is to begin at 1/10 of the dose that produces sum of erythema of 50 mm (approximately a 2+ positive skin test reaction).

For example, if a patient exhibits a 2+ intradermal reaction to 1 AU/mL, the first dose should be no higher than 0.05 mL of 0.1 AU/mL. Dosage may be increased by 0.05 mL each time until 0.5 mL is reached, at which time the next 10-fold more concentrated dilution can be used, beginning with 0.05 mL, if no untoward reaction is observed.

Interval between doses in the early stages of immunotherapy is no more than once to twice a week, and may gradually be increased to once every two weeks. Generally, maintenance injections may be given as infrequently as once every two weeks to once a month.

Injections are given subcutaneously, preferably in the arm. It is advantageous to give injections in alternate arms and routinely in the same area. In some patients, a local tolerance to the allergen may develop thus preventing a possible severe local reaction.

Formal stability studies for diluted and undiluted forms of unstandardized extracts have not been performed; therefore, it is recommended that minimal amounts of the concentrate be diluted so that the diluted product is used up within a relatively short period of time; i.e., preferably not more than four weeks.

PRE-SEASONAL METHOD OF TREATMENT

Treatment of hay fever by the pre-seasonal method should be started 6-10 weeks prior to the usual onset of symptoms. Therapy should be started early enough to permit a graduated series of doses at 2-7 day intervals. It is recommended that the larger doses be spaced 5-7 days apart.

Some physicians continue therapy into or through the season by repeating a reduced or MAINTENANCE dose at weekly or biweekly intervals. If during the season, hay fever symptoms develop, relief may be provided by giving supplemental treatment. If the last dose was well-tolerated and not more than 2 weeks has elapsed since it was given, this dose may be given again and repeated every 4 to 7 days.

PERENNIAL TREATMENT

The patient's tolerance to the offending pollen or pollens is first established by the injection of a series of graduated doses as outlined in the PRE-SEASONAL METHOD, not necessarily given pre-seasonally, since perennial therapy may be begun at any time. After completion of the ascending series of injections, from to of the highest well-tolerated dose is continued at 2 to 3 week intervals throughout the year. Shortly before the usual onset of symptoms (4 to 5 weeks prior to the season), the interval between injections is shortened and the dosage is gradually increased, according to the Pre-Seasonal schedule, until maximum well-tolerated dose is again attained. This top dose should be reached just before the usual onset of symptoms at which time the treatment is discontinued. If patient's symptoms persist, therapy may be continued at a reduced dosage level, usually to of the top dose.

DOSAGE ADJUSTMENTS

For Products Containing Short Ragweed.

In transferring patients from unstandardized to standardized product, the physician should establish the potency relationships, perhaps by comparative skin testing, prior to injecting the first standardized dose.

AgE is important in adjusting dosage of Short Ragweed extracts to accurately transfer a patient from older extracts to fresher material. In such cases, the dosage of AgE should be considered in addition to the W/V dilution or protein nitrogen units. Antigen E concentration continuously declines in Short Ragweed Pollen extracts at a rate that varies with the formulation of the product. Aqueous extracts retain Antigen E potency less effectively than glycerin 50% (v/v) extracts. These differences are reflected in the expiration date declared on the vial. The continuous decline should be considered. Also, where ragweed is a component of an allergen mixture, clinical response to the other components must be considered in adjustment of dosage based on AgE content alone. The usual course of immunotherapy is three to five years.

Caution: A small percent of individuals allergic to Short Ragweed are more sensitive to minor antigens such as Ra3 Ra5 than AgE. There is no correlation between the amount of these antigens and either AgE or PNU content.

NOTE: For extracts of Short Ragweed or equal part mixture of Short and Tall Ragweed refer to AgE dosage schedule. The AgE content for those products is indicated on the vial label. The physician may use the formula below to determine the AgE dosage for each injection.

AgE dosage can be monitored by using the following formula:

W/V compounded products:

AgE dosage formula: W/V compounded products.

PNU compounded products:

AgE dosage formula: PNU compounded products.

How Supplied 

  1. Treatment Sets:
    3 and 4 vial sets in serial dilutions prepared for therapy.
  2. Maintenance vials: 5 mL and 10 mL vials.
  3. Concentrate in multiple dose vials:
    10 mL and 50 mL, single antigens or specified mixtures, potency expressed in PNU/mL (up to and including 100,000 PNU/mL) or W/V (up to and including 1:10 W/V), aqueous or in 50% glycerin, to be diluted prior to use. 1:10 w/v short ragweed extracts contain 300 units/mL of AgE.
  4. Sterile Diluent for Allergenic Extracts (Phenol Saline) is supplied in vials of 4.5 mL, 9.0 mL, 30 mL and 100 mL.

STORAGE:

To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2o to 8o C even during use. Bulk or diluted extracts are not to be frozen. Do not use after the expiration date shown on the vial label.

References 

  1. Norman, P.S. et al: Immunotherapy of hayfever with ragweed antigen E. Comparisons with whole pollen extract and placebo. J. Allergy 42:93, 1968.
  2. Van Metre, T.E. et al: A controlled study of the effectiveness of the Rinkel method of immunotherapy for ragweed pollen hayfever. J. Allergy Clin.Immunol. 65:288, 1980.
  3. Umetsu, D. T. et al: Serum sickness triggered by anaphylaxis: a complication of immunotherapy. J. Allergy Clin. Immunol. 76:713, 1985.
  4. Phannphak, P. and Kohler, P. F.: Onset of polyarteritis nodosa during allergic hyposensitization treatment. Am. J. Med. 68:479, 1980.
  5. Kohler, P. F.: Immune complexes and allergic disease. In: Middleton et al: Allergy Principles and Practice 3rd Ed. St. Louis: CV Mosby, 1988:167.
  6. Bousquet, J.: In vivo methods for the study of allergy: skin test, techniques, and interpretation. In: Middleton et al: Allergy Principles and Practice 3rd Ed. St. Louis: CV Mosby, 1988:167.
  7. Committee on the Safety of Medicines. CSM update: desensitising vaccines. Brit. Med. J. 293:948, 1986.
  8. Lockey, R. F. et al: Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79:660, 1987.
  9. Reid, M.J. et al: Survey of fatalities from skin testing and immunotherapy. 1985-1989. J. Allergy Clin. Immunol. 92:6 1993.
  10. Van Metre, T.E. et al: A controlled study of the effectiveness of the Rinkel method and the current standard method of immunotherapy for ragweed pollen hayfever. J. Allergy Clin. Immunol. 66:500, 1980.
  11. Turkeltaub, P.C., Rastogi, S.C., Baer, H., et al: A standardized quantitative skin-test assay of allergen potency and stability: studies on the allergen dose-response curve and effect of wheal, erythema, and patient selection on assay results, J. Allergy Clin. Immunol. 70:343, 1982.

Revised June 2013

ALK-Abello, Inc. 2013 158L

Distributed in Canada by:
ALK-Abell Phamaceuticals, Inc.
#35-151 Brunel Road
Mississauga, Ontario
Canada L4Z 2H6

No Title 1572449379 

Principal Display Panel
Allergenic Extract
mL sterile multiple dose vial
ALK ABELLO

Allergenic Extract mL sterile multiple dose vial ALK ABELLO

EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0630
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0630-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0631
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0631-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0631-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0632
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0632-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0656
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0656-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0656-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CEIBA PENTANDRA FIBER
kapok injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0635
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEIBA PENTANDRA FIBER (UNII: 758Z9H9WV9) (CEIBA PENTANDRA FIBER - UNII:758Z9H9WV9) CEIBA PENTANDRA FIBER 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0635-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0635-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUS MUSCULUS SKIN
mouse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0638
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUS MUSCULUS SKIN (UNII: 390AN9GB09) (MUS MUSCULUS SKIN - UNII:390AN9GB09) MUS MUSCULUS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0638-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0638-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUS MUSCULUS SKIN
mouse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0639
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUS MUSCULUS SKIN (UNII: 390AN9GB09) (MUS MUSCULUS SKIN - UNII:390AN9GB09) MUS MUSCULUS SKIN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0639-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ORRIS
iris x germanica root injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0642
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRIS X GERMANICA ROOT (UNII: 8N6VTJ9IWV) (IRIS X GERMANICA ROOT - UNII:8N6VTJ9IWV) IRIS X GERMANICA ROOT 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0642-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0642-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RABBIT
rabbit injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0649
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0649-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RABBIT
rabbit injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0650
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0650-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0650-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RABBIT
rabbit injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0651
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0651-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0651-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0705
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0705-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0706
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0706-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0706-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0707
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0707-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0707-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0708
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0708-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0709
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0709-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0710
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0710-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PERIPLANETA AMERICANA
american cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0711
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0711-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0714
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0714-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0714-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0715
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0715-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0716
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0716-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0717
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0717-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0718
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0718-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0719
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0719-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0719-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0720
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0720-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BLATELLA GERMANICA
german cockroach injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0721
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0721-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACREMONIUM STRICTUM
sarocladium strictum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0800
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0800-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACREMONIUM STRICTUM
sarocladium strictum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0801
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0801-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0801-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACREMONIUM STRICTUM
sarocladium strictum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0802
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0802-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACREMONIUM STRICTUM
sarocladium strictum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0803
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0803-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0803-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0805
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0805-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0806
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0806-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0807
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0807-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0807-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0808
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0808-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0808-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0809
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0809-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0809-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0810
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0810-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0811
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0811-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0812
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0812-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0812-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0813
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.02 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0813-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0814
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0814-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0815
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0815-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0815-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALTERNARIA TENUIS
alternaria tenuis injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0816
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0816-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0816-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0817
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0817-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0817-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3 NDC:0268-0817-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0818
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0818-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0818-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0819
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0819-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0819-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0820
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0820-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0821
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0821-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0822
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0822-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0823
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.02 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0823-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0824
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0824-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0825
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0825-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0825-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0826
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0826-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0826-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS NIGER VAR NIGER
aspergillus niger injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0827
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0827-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0827-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS NIGER VAR NIGER
aspergillus niger injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0828
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0828-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0828-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS NIGER VAR NIGER
aspergillus niger injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0829
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0829-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ASPERGILLUS NIGER VAR NIGER
aspergillus niger injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0830
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0830-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0830-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AUREOBASIDIUM PULLULANS VAR PULLULANS
pullularia pullulans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0832
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0832-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0832-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3 NDC:0268-0832-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AUREOBASIDIUM PULLULANS VAR PULLULANS
pullularia pullulans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0833
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0833-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0833-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AUREOBASIDIUM PULLULANS VAR PULLULANS
pullularia pullulans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0834
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0834-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0834-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AUREOBASIDIUM PULLULANS VAR PULLULANS
pullularia pullulans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0835
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0835-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0835-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AUREOBASIDIUM PULLULANS VAR PULLULANS
pullularia pullulans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0836
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0836-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0836-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOTRYTIS CINEREA
botrytis cinerea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0837
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0837-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0837-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOTRYTIS CINEREA
botrytis cinerea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0838
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0838-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOTRYTIS CINEREA
botrytis cinerea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0839
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0839-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOTRYTIS CINEREA
botrytis cinerea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0840
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0840-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0840-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOTRYTIS CINEREA
botrytis cinerea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0841
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0841-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0842
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0842-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0843
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0843-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0843-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0844
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0844-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0844-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0845
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0845-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0845-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0846
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0846-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0847
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0847-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0848
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.02 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0848-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0849
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0849-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0849-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANDIDA ALBICANS
candida albicans injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0850
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0850-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHAETOMIUM GLOBOSUM
chaetomium globosum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0851
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0851-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0851-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHAETOMIUM GLOBOSUM
chaetomium globosum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0852
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0852-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0852-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHAETOMIUM GLOBOSUM
chaetomium globosum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0853
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0853-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0853-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0855
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0855-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0855-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0856
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0856-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0856-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0857
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0857-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0857-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0858
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0858-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0859
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0859-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0860
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0860-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM CLADOSPORIOIDES
cladosporium cladosporioides injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0861
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0861-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0861-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0863
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0863-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0863-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0864
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0864-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0864-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0865
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0865-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0865-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0866
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0866-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0867
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0867-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0868
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0868-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0868-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0869
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0869-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0870
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0870-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0870-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CLADOSPORIUM SPHAEROSPERMUM
cladosporium sphaerospermum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0871
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0871-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0871-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0878
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0878-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0878-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0879
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0879-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0879-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0880
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0880-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0880-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0881
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0881-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0882
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0882-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0882-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COCHLIOBOLUS SATIVUS
helminthosporium sorokinianum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0883
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0883-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0884
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0884-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0884-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3 NDC:0268-0884-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0885
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0885-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0885-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0886
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0886-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0886-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0887
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0887-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0888
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0888-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0889
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0889-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0890
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0890-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0891
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0891-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0892
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0892-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0892-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EPICOCCUM NIGRUM
epicoccum nigrum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0893
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0893-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0894
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0894-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0894-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0895
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0895-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0895-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0896
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0896-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0896-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0897
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0897-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0898
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0898-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0899
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0899-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0899-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0900
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0900-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0901
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0901-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0901-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FUSARIUM OXYSPORUM VASINFECTUM
fusarium vasinfectum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0902
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0902-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0902-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HELMINTHOSPORIUM SOLANI
helminthosporium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0903
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0903-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HELMINTHOSPORIUM SOLANI
helminthosporium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0904
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0904-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HELMINTHOSPORIUM SOLANI
helminthosporium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0905
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0905-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HELMINTHOSPORIUM SOLANI
helminthosporium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0906
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0906-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUCOR PLUMBEUS
mucor plumbeus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0911
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0911-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0911-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUCOR PLUMBEUS
mucor plumbeus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0912
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0912-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0912-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUCOR PLUMBEUS
mucor plumbeus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0913
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0913-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0913-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUCOR PLUMBEUS
mucor plumbeus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0914
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0914-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0914-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MUCOR PLUMBEUS
mucor plumbeus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0915
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0915-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0915-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
NEUROSPORA INTERMEDIA
neurospora intermedia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0916
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0916-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0916-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
NEUROSPORA INTERMEDIA
neurospora intermedia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0917
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0917-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0917-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
NEUROSPORA INTERMEDIA
neurospora intermedia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0918
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0918-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
NEUROSPORA INTERMEDIA
neurospora intermedia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0919
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0919-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0919-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
NEUROSPORA INTERMEDIA
neurospora intermedia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0920
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0920-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0921
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0921-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0921-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0922
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0922-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0922-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0923
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0923-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0923-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0924
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0924-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0925
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0925-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM
penicillium chrysogenum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0926
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0926-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0926-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0928
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0928-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0928-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0929
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0929-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0929-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0930
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0930-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0930-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0932
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0932-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0932-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0933
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0933-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PHOMA EXIGUA VAR EXIGUA
phoma herbarum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0931
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0931-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHIZOPUS ARRHIZUS VAR ARRHIZUS
rhizopus batatas injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0934
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0934-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0934-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHIZOPUS ARRHIZUS VAR ARRHIZUS
rhizopus batatas injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0935
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0935-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0935-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHIZOPUS ARRHIZUS VAR ARRHIZUS
rhizopus batatas injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0936
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0936-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0936-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHIZOPUS ARRHIZUS VAR ARRHIZUS
rhizopus batatas injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0937
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0937-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0937-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0939
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0939-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0939-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0940
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0940-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0941
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0941-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0942
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0942-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0943
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0943-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0943-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RHODOTORULA RUBRA
rhodotorula rubra injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0944
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0944-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
USTILAGO MAYDIS
corn smut injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0945
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0945-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0945-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
USTILAGO MAYDIS
corn smut injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0946
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0946-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
USTILAGO TRITICI
loose wheat smut injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0952
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO TRITICI (UNII: BV82OL2IZ8) (USTILAGO TRITICI - UNII:BV82OL2IZ8) USTILAGO TRITICI 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0952-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0952-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
STEMPHYLIUM SOLANI
stemphylium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0955
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0955-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0955-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
STEMPHYLIUM SOLANI
stemphylium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0956
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0956-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0956-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
STEMPHYLIUM SOLANI
stemphylium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0957
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0957-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0957-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
STEMPHYLIUM SOLANI
stemphylium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0958
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0958-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
STEMPHYLIUM SOLANI
stemphylium solani injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0959
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0959-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0959-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0961
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0961-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0961-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0962
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0962-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0962-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0963
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0963-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0965
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0965-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0966
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0966-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0967
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0967-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0967-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SACCHAROMYCES CEREVISIAE
saccharomyces cerevisiae injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0968
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0968-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SACCHAROMYCES CEREVISIAE
saccharomyces cerevisiae injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0969
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0969-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACACIA
acacia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1000
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACACIA (UNII: 5C5403N26O) (ACACIA - UNII:5C5403N26O) ACACIA 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1000-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1000-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACACIA
acacia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1001
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACACIA (UNII: 5C5403N26O) (ACACIA - UNII:5C5403N26O) ACACIA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1001-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1001-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AILANTHUS ALTISSIMA POLLEN
ailanthus tree of heaven injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1004
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (AILANTHUS ALTISSIMA POLLEN - UNII:2A64U81OQ3) AILANTHUS ALTISSIMA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1004-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1004-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALNUS INCANA SSP RUGOSA POLLEN
alder white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1007
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (ALNUS INCANA SUBSP. RUGOSA POLLEN - UNII:605T96G8Y5) ALNUS INCANA SUBSP. RUGOSA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1007-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1007-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALNUS INCANA SSP RUGOSA POLLEN
alder white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1008
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (ALNUS INCANA SUBSP. RUGOSA POLLEN - UNII:605T96G8Y5) ALNUS INCANA SUBSP. RUGOSA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1008-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1008-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ALNUS INCANA SSP RUGOSA POLLEN
alder white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1009
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (ALNUS INCANA SUBSP. RUGOSA POLLEN - UNII:605T96G8Y5) ALNUS INCANA SUBSP. RUGOSA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1009-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1009-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MEDICAGO SATIVA POLLEN
alfalfa injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1012
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY) (MEDICAGO SATIVA POLLEN - UNII:G515RAI9FY) MEDICAGO SATIVA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1012-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1012-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MEDICAGO SATIVA POLLEN
alfalfa injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1013
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY) (MEDICAGO SATIVA POLLEN - UNII:G515RAI9FY) MEDICAGO SATIVA POLLEN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1013-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS VELUTINA POLLEN
ash arizona injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1016
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1016-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS VELUTINA POLLEN
ash arizona injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1017
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1017-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1017-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3 NDC:0268-1017-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS VELUTINA POLLEN
ash arizona injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1018
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1018-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1021
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1021-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1022
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1022-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1022-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1023
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1023-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1023-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1024
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1024-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1024-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1025
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1025-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FRAXINUS AMERICANA POLLEN
ash white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1026
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1026-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS TREMULOIDES POLLEN
aspen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1029
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA) (POPULUS TREMULOIDES POLLEN - UNII:928OC2TJDA) POPULUS TREMULOIDES POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1029-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1029-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS TREMULOIDES POLLEN
aspen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1030
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA) (POPULUS TREMULOIDES POLLEN - UNII:928OC2TJDA) POPULUS TREMULOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1030-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1030-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1033
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1033-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1034
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1034-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1034-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1035
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1035-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1035-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1036
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1036-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1036-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1037
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1037-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PASPALUM NOTATUM POLLEN
bahia grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1038
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1038-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORELLA CERIFERA POLLEN
bayberry wax myrtle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1041
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89) MORELLA CERIFERA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1041-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1041-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORELLA CERIFERA POLLEN
bayberry wax myrtle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1042
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89) MORELLA CERIFERA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1042-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1042-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORELLA CERIFERA POLLEN
bayberry wax myrtle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1043
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89) MORELLA CERIFERA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1043-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FAGUS GRANDIFOLIA POLLEN
beech injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1046
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1046-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1046-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FAGUS GRANDIFOLIA POLLEN
beech injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1047
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1047-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1047-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FAGUS GRANDIFOLIA POLLEN
beech injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1048
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1048-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1048-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
FAGUS GRANDIFOLIA POLLEN
beech injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1049
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1049-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1056
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1056-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1056-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1057
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1057-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1057-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1058
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1058-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1059
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 50000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1059-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA NIGRA POLLEN
birch river red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1062
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1062-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1062-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA NIGRA POLLEN
birch river red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1063
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1063-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1063-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA NIGRA POLLEN
birch river red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1064
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1064-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA NIGRA POLLEN
birch river red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1065
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1065-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA NIGRA POLLEN
birch river red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1066
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1066-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1066-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1069
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1069-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1069-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1070
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1070-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1070-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1071
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1071-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1072
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1072-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BETULA LENTA POLLEN
birch white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1073
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1073-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1073-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POA ANNUA POLLEN
bluegrass annual injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1076
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA ANNUA POLLEN (UNII: 7U437HHU5C) (POA ANNUA POLLEN - UNII:7U437HHU5C) POA ANNUA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1076-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POA ANNUA POLLEN
bluegrass annual injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1077
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA ANNUA POLLEN (UNII: 7U437HHU5C) (POA ANNUA POLLEN - UNII:7U437HHU5C) POA ANNUA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1077-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER NEGUNDO POLLEN
box elder ash leaf maple injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1080
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1080-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1080-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER NEGUNDO POLLEN
box elder ash leaf maple injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1081
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1081-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1081-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER NEGUNDO POLLEN
box elder ash leaf maple injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1082
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1082-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1082-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER NEGUNDO POLLEN
box elder ash leaf maple injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1083
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1083-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BROMUS INERMIS POLLEN
brome grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1086
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1086-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1086-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BROMUS INERMIS POLLEN
brome grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1087
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1087-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1087-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BROMUS INERMIS POLLEN
brome grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1089
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1089-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS PALMERI POLLEN
carelessweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1092
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1092-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1092-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS PALMERI POLLEN
carelessweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1093
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1093-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1093-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS PALMERI POLLEN
carelessweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1094
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1094-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS ASHEI POLLEN
cedar mountain injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1097
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1097-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1097-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS ASHEI POLLEN
cedar mountain injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1098
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1098-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1098-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS ASHEI POLLEN
cedar mountain injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1099
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1099-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1099-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1102
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1102-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1102-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1103
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1103-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1103-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1104
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1104-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1105
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1105-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1106
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1106-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1106-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1107
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1107-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1110
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1110-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1110-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1111
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1111-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1111-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1112
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1112-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1112-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1113
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1113-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1114
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1114-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1115
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1115-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1116
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1116-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN
cocklebur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1117
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1117-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ZEA MAYS POLLEN
corn pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1120
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1120-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1120-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ZEA MAYS POLLEN
corn pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1121
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1121-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1121-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ZEA MAYS POLLEN
corn pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1122
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1122-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ZEA MAYS POLLEN
corn pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1123
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1123-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1126
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1126-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1126-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1127
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1127-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1127-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1128
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1128-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1128-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1129
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1129-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1129-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1130
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1130-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS FREMONTII POLLEN
cottonwood fremont injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1133
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (POPULUS FREMONTII POLLEN - UNII:426RHB4302) POPULUS FREMONTII POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1133-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS FREMONTII POLLEN
cottonwood fremont injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1134
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (POPULUS FREMONTII POLLEN - UNII:426RHB4302) POPULUS FREMONTII POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1134-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS FREMONTII POLLEN
cottonwood fremont injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1135
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (POPULUS FREMONTII POLLEN - UNII:426RHB4302) POPULUS FREMONTII POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1135-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES SSP MONILIFERA POLLEN
cottonwood western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1138
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441) (POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - UNII:5928LJ1441) POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1138-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES SSP MONILIFERA POLLEN
cottonwood western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1139
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441) (POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - UNII:5928LJ1441) POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1139-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1139-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CUPRESSUS ARIZONICA POLLEN
cypress arizona injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1142
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (CUPRESSUS ARIZONICA POLLEN - UNII:232DMH0XVF) CUPRESSUS ARIZONICA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1142-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CUPRESSUS ARIZONICA POLLEN
cypress arizona injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1143
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (CUPRESSUS ARIZONICA POLLEN - UNII:232DMH0XVF) CUPRESSUS ARIZONICA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1143-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1143-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TAXODIUM DISTICHUM POLLEN
cypress bald injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1146
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1146-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1146-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TAXODIUM DISTICHUM POLLEN
cypress bald injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1147
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1147-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1147-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TAXODIUM DISTICHUM POLLEN
cypress bald injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1148
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1148-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1151
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1151-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1151-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1152
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1152-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1152-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1153
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1153-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1153-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1154
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1154-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1155
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1155-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1155-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1156
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 60000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1156-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX CRISPUS POLLEN
dock yellow injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1159
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1159-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1159-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX CRISPUS POLLEN
dock yellow injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1160
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1160-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1160-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX CRISPUS POLLEN
dock yellow injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1161
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1161-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1161-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUPATORIUM CAPILLIFOLIUM POLLEN
dog fennel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1164
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (EUPATORIUM CAPILLIFOLIUM POLLEN - UNII:B67NF86HF0) EUPATORIUM CAPILLIFOLIUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1164-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1164-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUPATORIUM CAPILLIFOLIUM POLLEN
dog fennel non stock injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1165
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (EUPATORIUM CAPILLIFOLIUM POLLEN - UNII:B67NF86HF0) EUPATORIUM CAPILLIFOLIUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1165-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1165-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1168
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1168-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1168-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1169
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1169-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1169-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1170
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1170-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1170-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1171
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1171-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1172
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1172-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1607
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1607-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1174
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1174-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS CRASSIFOLIA POLLEN
elm cedar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1177
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I) (ULMUS CRASSIFOLIA POLLEN - UNII:G82398SD3I) ULMUS CRASSIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1177-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS CRASSIFOLIA POLLEN
elm cedar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1178
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I) (ULMUS CRASSIFOLIA POLLEN - UNII:G82398SD3I) ULMUS CRASSIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1178-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS PUMILA POLLEN
elm chinese injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1181
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS PUMILA POLLEN (UNII: 030R993R8E) (ULMUS PUMILA POLLEN - UNII:030R993R8E) ULMUS PUMILA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1181-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1181-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS PUMILA POLLEN
elm chinese injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1182
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS PUMILA POLLEN (UNII: 030R993R8E) (ULMUS PUMILA POLLEN - UNII:030R993R8E) ULMUS PUMILA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1182-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1182-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUCALYPTUS GLOBULUS POLLEN
eucalyptus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1185
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1185-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUCALYPTUS GLOBULUS POLLEN
eucalyptus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1186
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1186-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1186-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUCALYPTUS GLOBULUS POLLEN
eucalyptus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1187
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1187-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EUCALYPTUS GLOBULUS POLLEN
eucalyptus injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1188
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1188-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1191
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1191-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1192
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1192-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1192-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1193
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1193-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1608
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1608-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1195
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1195-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1195-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CELTIS OCCIDENTALIS POLLEN
hackberry injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1198
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1198-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1198-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CELTIS OCCIDENTALIS POLLEN
hackberry injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1199
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1199-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1199-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CELTIS OCCIDENTALIS POLLEN
hackberry injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1200
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1200-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CORYLUS AMERICANA POLLEN
hazelnut pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1203
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1203-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CORYLUS AMERICANA POLLEN
hazelnut pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1204
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1204-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1204-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CORYLUS AMERICANA POLLEN
hazelnut pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1205
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1205-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CORYLUS AMERICANA POLLEN
hazelnut pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1206
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1206-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1214
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1214-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1214-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1215
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1215-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1215-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1216
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1216-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1216-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1217
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1217-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1218
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1218-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1219
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1219-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SORGHUM HALEPENSE POLLEN
johnson grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1220
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1220-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS CALIFORNICA POLLEN
juniper western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1223
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1223-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS CALIFORNICA POLLEN
juniper western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1224
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1224-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1224-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS CALIFORNICA POLLEN
juniper western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1225
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1225-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1225-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
KOCHIA SCOPARIA POLLEN
kochia firebush injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1232
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1232-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1232-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
KOCHIA SCOPARIA POLLEN
kochia firebush injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1233
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1233-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1233-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
KOCHIA SCOPARIA POLLEN
kochia firebush injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1234
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1234-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1234-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
KOCHIA SCOPARIA POLLEN
kochia firebush injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1235
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1235-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1238
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1238-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1238-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1239
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1239-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1239-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1240
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1240-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1240-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1241
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1241-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1242
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1242-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ROBINIA PSEUDOACACIA POLLEN
locust black non stock injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1245
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROBINIA PSEUDOACACIA POLLEN (UNII: 8003NOJ82F) (ROBINIA PSEUDOACACIA POLLEN - UNII:8003NOJ82F) ROBINIA PSEUDOACACIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1245-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER RUBRUM POLLEN
maple red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1248
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1248-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1248-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER RUBRUM POLLEN
maple red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1249
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1249-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1249-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER SACCHARUM POLLEN
maple sugar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1252
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1252-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1252-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER SACCHARUM POLLEN
maple sugar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1253
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1253-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1253-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER SACCHARUM POLLEN
maple sugar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1254
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1254-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1254-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ACER SACCHARUM POLLEN
maple sugar injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1255
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1255-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA XANTHIFOLIA POLLEN
marshelder burweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1258
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1258-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1258-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA XANTHIFOLIA POLLEN
marshelder burweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1259
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1259-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1259-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA XANTHIFOLIA POLLEN
marshelder burweed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1260
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1260-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1260-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA ANNUA VAR ANNUA POLLEN
marshelder rough injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1263
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1263-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1263-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA ANNUA VAR ANNUA POLLEN
marshelder rough injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1264
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1264-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1264-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA ANNUA VAR ANNUA POLLEN
marshelder rough injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1265
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1265-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1265-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
IVA ANNUA VAR ANNUA POLLEN
marshelder rough injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1266
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1266-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MELALEUCA QUINQUENERVIA POLLEN
melaleuca pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1273
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1273-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1273-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MELALEUCA QUINQUENERVIA POLLEN
melaleuca pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1274
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1274-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1274-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MELALEUCA QUINQUENERVIA POLLEN
melaleuca pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1275
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1275-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MELALEUCA QUINQUENERVIA POLLEN
melaleuca pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1276
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1276-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1276-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PROSOPIS JULIFLORA POLLEN
mesquite injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1279
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1279-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1279-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PROSOPIS JULIFLORA POLLEN
mesquite injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1280
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1280-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1280-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PROSOPIS JULIFLORA POLLEN
mesquite injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1281
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1281-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM AMBROSIOIDES POLLEN
mexican tea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1284
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1284-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1284-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
CHENOPODIUM AMBROSIOIDES POLLEN
mexican tea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1285
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1285-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1285-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
CHENOPODIUM AMBROSIOIDES POLLEN
mexican tea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1286
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1286-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1286-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
ARTEMISIA VULGARIS POLLEN
mugwort common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1297
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1297-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1297-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA VULGARIS POLLEN
mugwort common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1298
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1298-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1298-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA VULGARIS POLLEN
mugwort common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1299
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1299-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1299-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA VULGARIS POLLEN
mugwort common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1300
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1300-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1300-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA VULGARIS POLLEN
mugwort common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1301
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1301-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS RUBRA POLLEN
mulberry red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1304
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1304-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1304-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS RUBRA POLLEN
mulberry red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1305
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1305-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1305-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS RUBRA POLLEN
mulberry red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1306
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1306-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1306-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS RUBRA POLLEN
mulberry red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1307
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1307-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS ALBA POLLEN
mulberry white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1310
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1310-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1310-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
MORUS ALBA POLLEN
mulberry white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1311
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1311-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1311-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS AGRIFOLIA POLLEN
oak california live coast injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1314
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (QUERCUS AGRIFOLIA POLLEN - UNII:VOT5MA71M7) QUERCUS AGRIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1314-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1314-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS AGRIFOLIA POLLEN
oak california live coast injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1315
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (QUERCUS AGRIFOLIA POLLEN - UNII:VOT5MA71M7) QUERCUS AGRIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1315-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1315-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS RUBRA POLLEN
oak red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1318
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1318-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1318-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS RUBRA POLLEN
oak red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1319
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1319-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1319-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS VIRGINIANA POLLEN
oak virginia live injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1322
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1322-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1322-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS VIRGINIANA POLLEN
oak virginia live injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1323
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1323-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1323-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS VIRGINIANA POLLEN
oak virginia live injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1324
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1324-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1327
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1327-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1327-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1328
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1328-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1328-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1329
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1329-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1329-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1330
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1330-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1613
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1613-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1332
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 50000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1332-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1333
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1333-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oat wild pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1336
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1336-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1336-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
OLEA EUROPAEA POLLEN
olive pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1339
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627) OLEA EUROPAEA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1339-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1339-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
OLEA EUROPAEA POLLEN
olive pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1340
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627) OLEA EUROPAEA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1340-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1340-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SYAGRUS ROMANZOFFIANA POLLEN
palm queen coco palm injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1347
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (SYAGRUS ROMANZOFFIANA POLLEN - UNII:84ZOM591BB) SYAGRUS ROMANZOFFIANA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1347-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1347-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SYAGRUS ROMANZOFFIANA POLLEN
palm queen coco palm injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1348
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (SYAGRUS ROMANZOFFIANA POLLEN - UNII:84ZOM591BB) SYAGRUS ROMANZOFFIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1348-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1348-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1354
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1354-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1354-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1355
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1355-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1355-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1614
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1614-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1358
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1358-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SCHINUS MOLLE POLLEN
pepper tree california injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1361
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1) (SCHINUS MOLLE POLLEN - UNII:M0G28FH9K1) SCHINUS MOLLE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1361-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1361-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1364
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1364-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1364-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1365
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1365-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1365-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1366
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1366-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1366-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1367
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1367-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1368
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1368-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS SPINOSUS POLLEN
pigweed spiny injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1371
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1371-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1371-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS SPINOSUS POLLEN
pigweed spiny injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1372
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1372-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1372-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS SPINOSUS POLLEN
pigweed spiny injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1373
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1373-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CASUARINA EQUISETIFOLIA POLLEN
pine australian beefwood injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1376
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1376-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1376-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CASUARINA EQUISETIFOLIA POLLEN
pine australian beefwood injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1377
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1377-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1377-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CASUARINA EQUISETIFOLIA POLLEN
pine australian beefwood injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1378
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1378-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CASUARINA EQUISETIFOLIA POLLEN
pine australian beefwood injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1379
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 50000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1379-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1379-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS STROBUS POLLEN
pine white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1382
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1382-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1382-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS STROBUS POLLEN
pine white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1383
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1383-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1383-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS STROBUS POLLEN
pine white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1384
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1384-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS STROBUS POLLEN
pine white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1385
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1385-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS STROBUS POLLEN
pine white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1386
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1386-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS ECHINATA POLLEN
pine yellow injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1389
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS ECHINATA POLLEN (UNII: 96LRW14765) (PINUS ECHINATA POLLEN - UNII:96LRW14765) PINUS ECHINATA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1389-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1389-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PINUS ECHINATA POLLEN
pine yellow injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1390
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS ECHINATA POLLEN (UNII: 96LRW14765) (PINUS ECHINATA POLLEN - UNII:96LRW14765) PINUS ECHINATA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1390-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1390-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1394
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1394-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1394-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1395
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1395-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1395-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1396
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1396-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1397
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1397-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1397-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1616
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1616-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1399
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1399-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1399-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1400
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1400-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1400-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1401
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1401-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1402
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1402-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS ALBA POLLEN
poplar white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1405
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1405-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1405-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS ALBA POLLEN
poplar white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1406
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1406-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1406-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS ALBA POLLEN
poplar white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1407
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1407-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1407-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS ALBA POLLEN
poplar white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1408
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1408-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS ALBA POLLEN
poplar white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1409
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1409-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIGUSTRUM VULGARE POLLEN
privet injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1412
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1412-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1412-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIGUSTRUM VULGARE POLLEN
privet injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1413
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1413-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1413-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIGUSTRUM VULGARE POLLEN
privet injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1414
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1414-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIGUSTRUM VULGARE POLLEN
privet injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1415
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1415-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 08/01/2017
ELYMUS REPENS POLLEN
quack grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1418
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1418-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1418-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ELYMUS REPENS POLLEN
quack grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1419
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1419-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ELYMUS REPENS POLLEN
quack grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1420
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1420-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ACANTHICARPA POLLEN
ragweed false bur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1423
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y) (AMBROSIA ACANTHICARPA POLLEN - UNII:U2AI3H2J5Y) AMBROSIA ACANTHICARPA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1423-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1423-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ACANTHICARPA POLLEN
ragweed false bur injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1424
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y) (AMBROSIA ACANTHICARPA POLLEN - UNII:U2AI3H2J5Y) AMBROSIA ACANTHICARPA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1424-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1424-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TENUIFOLIA POLLEN
ragweed slender injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1431
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TENUIFOLIA POLLEN (UNII: 57W5SO585B) (AMBROSIA TENUIFOLIA POLLEN - UNII:57W5SO585B) AMBROSIA TENUIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1431-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TENUIFOLIA POLLEN
ragweed slender injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1432
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TENUIFOLIA POLLEN (UNII: 57W5SO585B) (AMBROSIA TENUIFOLIA POLLEN - UNII:57W5SO585B) AMBROSIA TENUIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1432-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA BIDENTATA POLLEN
ragweed southern injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1435
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (AMBROSIA BIDENTATA POLLEN - UNII:M3S672G75O) AMBROSIA BIDENTATA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1435-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1435-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA BIDENTATA POLLEN
ragweed southern injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1436
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (AMBROSIA BIDENTATA POLLEN - UNII:M3S672G75O) AMBROSIA BIDENTATA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1436-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1436-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ARTEMISIIFOLIA POLLEN
ragweed short injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1531
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1531-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1531-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ARTEMISIIFOLIA POLLEN
ragweed short injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1532
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1532-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1532-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ARTEMISIIFOLIA POLLEN
ragweed short injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1533
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1533-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA ARTEMISIIFOLIA POLLEN
ragweed short injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1534
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1534-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1534-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TRIFIDA POLLEN
ragweed tall giant injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1439
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1439-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1439-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TRIFIDA POLLEN
ragweed tall giant injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1440
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1440-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1440-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TRIFIDA POLLEN
ragweed tall giant injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1441
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1441-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA TRIFIDA POLLEN
ragweed tall giant injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1442
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1442-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA PSILOSTACHYA POLLEN
ragweed western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1445
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1445-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1445-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMBROSIA PSILOSTACHYA POLLEN
ragweed western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1446
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1446-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1446-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALSOLA KALI POLLEN
russian thistle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1453
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1453-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1453-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALSOLA KALI POLLEN
russian thistle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1454
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1454-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1454-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALSOLA KALI POLLEN
russian thistle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1455
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1455-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1455-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALSOLA KALI POLLEN
russian thistle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1456
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1456-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALSOLA KALI POLLEN
russian thistle injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1457
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1457-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LOLIUM PERENNE SSP MULTIFLORUM POLLEN
rye grass italian injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1460
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOLIUM MULTIFLORUM POLLEN (UNII: VJI0WKK736) (LOLIUM MULTIFLORUM POLLEN - UNII:VJI0WKK736) LOLIUM MULTIFLORUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1460-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA FRIGIDA POLLEN
sage prairie injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1467
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA FRIGIDA POLLEN (UNII: 5AN5LR8L3F) (ARTEMISIA FRIGIDA POLLEN - UNII:5AN5LR8L3F) ARTEMISIA FRIGIDA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1467-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA FRIGIDA POLLEN
sage prairie injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1468
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA FRIGIDA POLLEN (UNII: 5AN5LR8L3F) (ARTEMISIA FRIGIDA POLLEN - UNII:5AN5LR8L3F) ARTEMISIA FRIGIDA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1468-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1468-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA TRIDENTATA POLLEN
sagebrush common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1471
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1471-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1471-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA TRIDENTATA POLLEN
sagebrush common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1472
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1472-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1472-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA TRIDENTATA POLLEN
sagebrush common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1473
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1473-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
DISTICHLIS SPICATA POLLEN
salt grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1476
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV) (DISTICHLIS SPICATA POLLEN - UNII:GOA51670YV) DISTICHLIS SPICATA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1476-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1476-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
DISTICHLIS SPICATA POLLEN
salt grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1477
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV) (DISTICHLIS SPICATA POLLEN - UNII:GOA51670YV) DISTICHLIS SPICATA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1477-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1477-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ATRIPLEX WRIGHTII POLLEN
saltbush annual atriplex injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1480
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O) (ATRIPLEX WRIGHTII POLLEN - UNII:YB1308W43O) ATRIPLEX WRIGHTII POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1480-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1480-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ATRIPLEX WRIGHTII POLLEN
saltbush annual atriplex injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1481
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O) (ATRIPLEX WRIGHTII POLLEN - UNII:YB1308W43O) ATRIPLEX WRIGHTII POLLEN 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1481-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1481-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1493
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1493-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1493-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1494
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1494-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1494-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1495
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1495-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1496
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1496-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1497
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1497-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
LIQUIDAMBAR STYRACIFLUA POLLEN
sweetgum injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1498
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1498-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLATANUS OCCIDENTALIS POLLEN
sycamore american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1501
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1501-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1501-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLATANUS OCCIDENTALIS POLLEN
sycamore american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1502
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1502-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1502-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLATANUS OCCIDENTALIS POLLEN
sycamore american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1503
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1503-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1503-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLATANUS OCCIDENTALIS POLLEN
sycamore american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1504
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1504-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLATANUS OCCIDENTALIS POLLEN
sycamore american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1505
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1505-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HOLCUS LANATUS POLLEN
velvet grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1510
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01) HOLCUS LANATUS POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1510-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1510-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
HOLCUS LANATUS POLLEN
velvet grass injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1511
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01) HOLCUS LANATUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1511-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS NIGRA POLLEN
walnut black pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1512
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1512-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1512-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS NIGRA POLLEN
walnut black pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1513
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1513-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1513-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS NIGRA POLLEN
walnut black pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1514
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1514-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1514-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS NIGRA POLLEN
walnut california black pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1515
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1515-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS REGIA POLLEN
walnut english pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1516
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS REGIA POLLEN (UNII: ARW43087I1) (JUGLANS REGIA POLLEN - UNII:ARW43087I1) JUGLANS REGIA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1516-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUGLANS REGIA POLLEN
walnut english pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1517
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS REGIA POLLEN (UNII: ARW43087I1) (JUGLANS REGIA POLLEN - UNII:ARW43087I1) JUGLANS REGIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1517-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1517-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS TUBERCULATUS POLLEN
water hemp injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1518
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1518-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1518-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS TUBERCULATUS POLLEN
water hemp injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1519
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1519-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1519-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS TUBERCULATUS POLLEN
water hemp injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1520
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1520-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1520-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
AMARANTHUS TUBERCULATUS POLLEN
water hemp injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1521
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1521-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRITICUM AESTIVUM POLLEN
wheat pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1522
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (TRITICUM AESTIVUM POLLEN - UNII:F1KAH8374D) TRITICUM AESTIVUM POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1522-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1522-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
TRITICUM AESTIVUM POLLEN
wheat pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1523
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (TRITICUM AESTIVUM POLLEN - UNII:F1KAH8374D) TRITICUM AESTIVUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1523-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1523-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1524
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1524-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1524-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1525
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1525-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1525-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1526
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1526-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1526-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1527
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1527-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1527-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1528
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1528-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SALIX NIGRA POLLEN
willow black injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1529
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1529-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ARTEMISIA ANNUA POLLEN
wormwood common annual injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1530
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1530-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1530-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1601
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1601-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RABBIT
rabbit injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0652
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0652-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS ASHEI POLLEN
cedar mountain injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1602
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1602-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1603
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1603-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS VIRGINIANA POLLEN
cedar red injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1604
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1604-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
POPULUS DELTOIDES POLLEN
cottonwood eastern common injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1605
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1605-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
RUMEX ACETOSELLA POLLEN
dock sour sheep sorrel injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1606
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1606-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
ULMUS AMERICANA POLLEN
elm american injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1173
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1173-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
SOLIDAGO CANADENSIS POLLEN
goldenrod injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1194
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1194-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
JUNIPERUS CALIFORNICA POLLEN
juniper western injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1609
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1609-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM ALBUM POLLEN
lambs quarters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1610
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1610-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CHENOPODIUM AMBROSIOIDES POLLEN
mexican tea injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1611
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1611-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-1611-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
QUERCUS AGRIFOLIA POLLEN
oak california live coast injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1612
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (QUERCUS AGRIFOLIA POLLEN - UNII:VOT5MA71M7) QUERCUS AGRIFOLIA POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1612-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
QUERCUS ALBA POLLEN
oak white injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1331
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1331-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1356
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1356-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CARYA ILLINOINENSIS POLLEN
pecan pollen injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1357
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1357-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PLANTAGO LANCEOLATA POLLEN
plantain english injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1398
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1398-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PYRETHRUM CINERARIIFOLIUM
pyrethrum cinerariifolium injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0645
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TANACETUM CINERARIIFOLIUM FLOWER (UNII: CGF76TP7X6) (TANACETUM CINERARIIFOLIUM FLOWER - UNII:CGF76TP7X6) TANACETUM CINERARIIFOLIUM FLOWER 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0645-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
PYRETHRUM CINERARIIFOLIUM
pyrethrum cinerariifolium injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0646
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TANACETUM CINERARIIFOLIUM FLOWER (UNII: CGF76TP7X6) (TANACETUM CINERARIIFOLIUM FLOWER - UNII:CGF76TP7X6) TANACETUM CINERARIIFOLIUM FLOWER 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0646-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 02/23/1998
AMARANTHUS RETROFLEXUS POLLEN
pigweed rough redroot injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1615
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1615-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 02/23/1998
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0001
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0001-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0002
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0002-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0003
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0003-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0004
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0004-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0004-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0005
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0005-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0005-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0006
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0006-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0007
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0007-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0007-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0008
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 500 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0008-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0009
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0009-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0009-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0010
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0010-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0011
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0011-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0011-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0012
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0012-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0012-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
HOUSE DUST
house dust injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0013
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0013-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0013-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965 06/30/2013
BOS TAURUS SKIN
cattle epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0603
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0603-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0603-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOS TAURUS SKIN
cattle epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0604
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0604-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOS TAURUS SKIN
cattle epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0605
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0605-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
BOS TAURUS SKIN
cattle epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0606
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0606-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COTTON FIBER
cotton linters injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0609
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COTTON FIBER (UNII: 70LDW53ROO) (COTTON FIBER - UNII:70LDW53ROO) COTTON FIBER 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0609-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0609-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
COTTON SEED
cottonseed injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0612
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COTTON SEED (UNII: DI0ZRJ0MXN) (COTTON SEED - UNII:DI0ZRJ0MXN) COTTON SEED 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0612-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0615
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0615-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0615-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0616
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0616-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0617
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 10 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0617-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0618
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 100 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0618-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0618-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0619
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0619-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0619-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0620
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0620-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0620-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0621
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.05 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0621-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0621-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0622
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0622-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0623
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.0005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0623-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0624
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0624-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0624-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0625
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0625-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0626
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0626-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0626-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0627
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0627-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CANIS LUPUS FAMILIARIS SKIN
dog epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1600
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-1600-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CAVIA PORCELLUS SKIN
guinea pig epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0653
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0653-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0653-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CAVIA PORCELLUS SKIN
guinea pig epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0654
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0654-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
CAVIA PORCELLUS SKIN
guinea pig epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0655
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0655-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0655-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0628
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.10 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0628-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0628-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3 NDC:0268-0628-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
EQUUS CABALLUS SKIN
horse epithelia injection, solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0629
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 10000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0268-0629-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2 NDC:0268-0629-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103753 01/01/1965
Labeler - ALK-Abello, Inc. (809998847)

Revised: 8/2017 ALK-Abello, Inc.



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