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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-250
Application NumberNDA022186
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluorescein sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 15, 2016
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-253
Application NumberNDA022186
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluorescein sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 15, 2016
FDA Product Classification
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