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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21922-041
Application NumberANDA215612
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluorouracil
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 7, 2023
FDA Product Classification
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