NDC 66758-054

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 ID66758-054_1b835751-d6a4-49b6-b0f8-23ab31b0d04e
NDC66758-054
Product TypeHuman Prescription Drug
Proprietary NameFluorouracil
Generic NameFluorouracil
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-05-02
Marketing CategoryANDA / ANDA
Application NumberANDA091299
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 66758-054-02

1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (66758-054-02) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
Marketing Start Date2011-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66758-054-02 [66758005402]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA091299
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-02
Inactivation Date2019-10-29

NDC 66758-054-01 [66758005401]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA091299
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-02
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL50 mg/mL

OpenFDA Data

SPL SET ID:1b835751-d6a4-49b6-b0f8-23ab31b0d04e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 239177
  • 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

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