Fluorouracil
Fluorouracil Topical Cream USP, 5%
Approved
Approval ID
9a2c044d-83e4-42b4-9797-c344b8d3d152
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2010
Manufacturers
FDA
Taro Pharmaceutical Industries Ltd.
DUNS: 600072078
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 Code52549-4118
Application NumberANDA090368
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluorouracil
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (8)
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
FluorouracilActive
Quantity: 50 mg in 1 g
Code: U3P01618RT
Classification: ACTIB
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT