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 use Pharmacy Bulk Package - Not for Direct Infusion Initial U.S. Approval: 1962
Approved
Approval ID
8eff167f-203a-4a81-b2fc-d8773bc3555e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2017
Manufacturers
FDA
Accord Healthcare, Inc.
DUNS: 604222237
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 Code16729-276
Application NumberANDA040798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluorouracil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 23, 2017
FDA Product Classification
INGREDIENTS (3)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FLUOROURACILActive
Quantity: 50 mg in 1 mL
Code: U3P01618RT
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT