NDC 66758-044

Fluorouracil

Fluorouracil

Fluorouracil is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Fluorouracil.

Product ID66758-044_19dd287f-9d5d-4742-913f-25afa34bf277
NDC66758-044
Product TypeHuman Prescription Drug
Proprietary NameFluorouracil
Generic NameFluorouracil
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2008-09-10
Marketing CategoryANDA / ANDA
Application NumberANDA040772
Labeler NameSandoz Inc
Substance NameFLUOROURACIL
Active Ingredient Strength50 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 66758-044-03

10 VIAL, SINGLE-USE in 1 CARTON (66758-044-03) > 10 mL in 1 VIAL, SINGLE-USE (66758-044-01)
Marketing Start Date2008-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66758-044-01 [66758004401]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040772
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-09-10
Marketing End Date2014-10-07

NDC 66758-044-03 [66758004403]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040772
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-09-10
Marketing End Date2014-10-07
Inactivation Date2019-10-21
Reactivation Date2020-05-04

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL50 mg/mL

OpenFDA Data

SPL SET ID:1911e06a-2f16-4b99-adfa-4b914d559e1e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1791701

    • Pharmacological Class

    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleoside Metabolic Inhibitor [EPC]

    NDC Crossover Matching brand name "Fluorouracil" or generic name "Fluorouracil"

    NDCBrand NameGeneric Name
    0378-4791FluorouracilFluorouracil
    16714-178FluorouracilFluorouracil
    16729-276FluorouracilFluorouracil
    16729-542FluorouracilFluorouracil
    21695-829FLUOROURACILfluorouracil
    25021-215fluorouracilfluorouracil
    68001-266FluorouracilFluorouracil
    68083-293FluorouracilFluorouracil
    68083-292FluorouracilFluorouracil
    68083-269FluorouracilFluorouracil
    68083-270FluorouracilFluorouracil
    43547-259FluorouracilFluorouracil
    43547-258FluorouracilFluorouracil
    51672-4063FluorouracilFluorouracil
    51672-4062FluorouracilFluorouracil
    51672-4118FluorouracilFluorouracil
    52549-4118FluorouracilFluorouracil
    63323-117FluorouracilFluorouracil
    66758-044FluorouracilFluorouracil
    66758-054FluorouracilFluorouracil
    66530-249FLUOROURACILFLUOROURACIL
    66530-258FluorouracilFluorouracil
    50090-4264FluorouracilFluorouracil
    51862-362FLUOROURACILFLUOROURACIL
    50742-483FLUOROURACILFLUOROURACIL
    50742-481FLUOROURACILFLUOROURACIL
    50742-423FLUOROURACILFLUOROURACIL
    50742-482FLUOROURACILFLUOROURACIL
    0703-3015AdrucilFluorouracil
    0703-3018AdrucilFluorouracil
    0703-3019AdrucilFluorouracil
    0187-5200Caracfluorouracil
    0187-3204EfudexFluorouracil
    16110-812Fluoroplexfluorouracil
    0378-8078Fluorouracil Creamfluorouracil
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.