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AK-FLUOR- fluorescein sodium injection


  1. Patient Information
  2. Principal Display Panel Text For Container Label:
  3. Principal Display Panel Text For Carton Label:
  4. Revised: 8/2019document Id:

Patient Information 

After administration of fluorescein sodium, skin will attain a temporary yellowish discoloration. Urine attains a bright yellow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours. [seeWarnings and Precautions (6.1)].

Rx only

Akorn

Manufactured by:
Akorn Inc.
Lake Forest, IL 60045

FL00N Rev. 08/19

Principal Display Panel Text For Container Label: 

NDC 17478-250-20

AK-FLUOR25%

Fluorescein Injection, USP

250 mg/mL

Rx only

2mL Sterile Vial

For IV Injection.

Principal Display Panel Text for Carton Label:

Principal Display Panel Text For Carton Label: 

Akorn Logo NDC 17478-250-20

AK-FLUOR25%

Fluorescein Injection, USP

Rx only 250 mg/mL/12 Sterile Vials (2 mL each)

Principal Display Panel Text for Carton Label:
AK-FLUOR
fluorescein sodium injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-253
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fluorescein sodium(UNII: 93X55PE38X) (fluorescein - UNII:TPY09G7XIR)fluorescein100 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-253-1012 in 1 PACKAGE10/01/2008
15 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02218610/01/2008
AK-FLUOR
fluorescein sodium injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-250
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fluorescein sodium(UNII: 93X55PE38X) (fluorescein - UNII:TPY09G7XIR)fluorescein250 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-250-2012 in 1 PACKAGE10/01/2008
12 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02218610/01/2008
Labeler -Akorn (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc155135783MANUFACTURE(17478-253, 17478-250) , REPACK(17478-253, 17478-250) , ANALYSIS(17478-253, 17478-250)

Revised: 8/2019document Id: 

a9149e8f-1455-4d56-a986-c0c48bc69bfaSet id: a1823be3-a739-48bc-a3ea-ceb7cc5105ceVersion: 9Effective Time: 20190831Akorn



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