FLUOROURACIL
Fluorouracil Cream, USP 5%
Approved
Approval ID
06475bd8-66d9-4f88-90e4-b367480dab39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 4, 2021
Manufacturers
FDA
Mayne Pharma Inc.
DUNS: 867220261
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 Code51862-362
Application NumberANDA077524
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUOROURACIL
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 4, 2021
FDA Product Classification
INGREDIENTS (9)
FLUOROURACILActive
Quantity: 50 mg in 1 g
Code: U3P01618RT
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT