AK-FLUOR
These highlights do not include all the information needed to use AK-FLUOR 10% and AK-FLUOR 25% safely and effectively. See full prescribing information for the products in AK-FLUOR 10% and AK-FLUOR 25%. AK-FLUOR (fluorescein injection, USP) 10% and AK-FLUOR (fluorescein injection, USP) 25%Intravenous injection Initial U.S. Approval: 1976
Approved
Approval ID
a1823be3-a739-48bc-a3ea-ceb7cc5105ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2022
Manufacturers
FDA
Akorn
DUNS: 117693100
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluorescein sodium
PRODUCT DETAILS
NDC Product Code17478-250
Application NumberNDA022186
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateAugust 15, 2016
Generic Namefluorescein sodium
INGREDIENTS (4)
fluorescein sodiumActive
Quantity: 250 mg in 1 mL
Code: 93X55PE38X
Classification: ACTIM
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
fluorescein sodium
PRODUCT DETAILS
NDC Product Code17478-253
Application NumberNDA022186
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateAugust 15, 2016
Generic Namefluorescein sodium
INGREDIENTS (4)
fluorescein sodiumActive
Quantity: 100 mg in 1 mL
Code: 93X55PE38X
Classification: ACTIM
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT