Fluorouracil
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 Initial U.S. Approval: 1962
Approved
Approval ID
9c42eeff-ab0c-4820-94d7-e1a3df9fda74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2023
Manufacturers
FDA
BluePoint Laboratories
DUNS: 985523874
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 Code68001-524
Application NumberANDA210123
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluorouracil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 27, 2023
FDA Product Classification
INGREDIENTS (3)
FLUOROURACILActive
Quantity: 50 mg in 1 mL
Code: U3P01618RT
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT