Fluorouracil
Fluorouracil Cream USP, 5%
Approved
Approval ID
03b1a351-5a63-5bcb-e063-6294a90a7c5c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2023
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluorouracil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-3489
Application NumberANDA090368
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluorouracil
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (8)
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
FLUOROURACILActive
Quantity: 50 mg in 1 g
Code: U3P01618RT
Classification: ACTIB