Fluorescein
These highlights do not include all the information needed to use FLUORESCEIN INJECTION safely and effectively. See full prescribing information for FLUORESCEIN INJECTION.FLUORESCEIN injection, for intravenous use Initial U.S. Approval: 1976
Approved
Approval ID
0a2a65b1-dc88-445b-bfb7-53b2fd7bea2c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Nexus Pharmaceuticals LLC
DUNS: 620714787
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluorescein
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14789-123
Application NumberANDA215709
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluorescein
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (4)
FluoresceinActive
Quantity: 250 mg in 1 mL
Code: TPY09G7XIR
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Fluorescein
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14789-122
Application NumberANDA215709
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluorescein
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (4)
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
FluoresceinActive
Quantity: 500 mg in 1 mL
Code: TPY09G7XIR
Classification: ACTIB
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT