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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 P