NDC 21695-829

FLUOROURACIL

Fluorouracil

FLUOROURACIL is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Fluorouracil.

Product ID21695-829_4d8f6f8f-a69a-48db-8ee1-3b23989cb11f
NDC21695-829
Product TypeHuman Prescription Drug
Proprietary NameFLUOROURACIL
Generic NameFluorouracil
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2008-04-11
Marketing CategoryANDA / ANDA
Application NumberANDA077524
Labeler NameRebel Distributors Corp
Substance NameFLUOROURACIL
Active Ingredient Strength50 mg/g
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-829-40

40 g in 1 TUBE (21695-829-40)
Marketing Start Date2008-04-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-829-40 [21695082940]

FLUOROURACIL CREAM
Marketing CategoryANDA
Application NumberANDA077524
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2008-04-11
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL50 mg/g

OpenFDA Data

SPL SET ID:4d8f6f8f-a69a-48db-8ee1-3b23989cb11f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 105583
  • 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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