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
NDC Product Code68071-3489
Application NumberANDA090368
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateAugust 24, 2023
Generic NameFluorouracil
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