FLUORESCEIN
AK-FLUOR® 10% FLUORESCEIN INJECTION, USP 100mg/mL 5mL VIAL
Approved
Approval ID
c1ffe119-7fba-940f-e053-2a95a90a7a17
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2021
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 1
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 Code51662-1533
Application NumberNDA022186
Product Classification
M
Marketing Category
C73594
G
Generic Name
FLUORESCEIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 8, 2021
FDA Product Classification
INGREDIENTS (4)
FLUORESCEIN SODIUMActive
Quantity: 100 mg in 1 mL
Code: 93X55PE38X
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT