Fluorouracil
FLUOROURACIL TOPICAL SOLUTION Rx only FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
Approved
Approval ID
2c631ce7-ea15-4b51-b5bc-4962e3c315cd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
Encube Ethicals Private Limited
DUNS: 915834105
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 Code21922-041
Application NumberANDA215612
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateNovember 7, 2023
Generic NameFluorouracil
INGREDIENTS (8)
FLUOROURACILActive
Quantity: 50 mg in 1 mL
Code: U3P01618RT
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT