Fluorouracil
These highlights do not include all the information needed to use FLUOROURACIL injection safely and effectively. See full prescribing information for FLUOROURACIL injection. FLUOROURACIL injection, for intravenous usePharmacy Bulk Package - Not for Direct InfusionInitial U.S. Approval: 1962
Approved
Approval ID
21af1777-87f7-4e40-9917-f1677e7ff1a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2017
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code63323-117
Application NumberANDA040278
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateApril 24, 2017
Generic NameFLUOROURACIL
INGREDIENTS (2)
FLUOROURACILActive
Quantity: 50 mg in 1 mL
Code: U3P01618RT
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT