NDC 43547-258

Fluorouracil

Fluorouracil

Fluorouracil is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Solco Healthcare Us Llc. The primary component is Fluorouracil.

Product ID43547-258_f11232f0-6ba0-4719-94cd-6f04562f2542
NDC43547-258
Product TypeHuman Prescription Drug
Proprietary NameFluorouracil
Generic NameFluorouracil
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2010-06-01
Marketing CategoryNDA / NDA
Application NumberNDA016831
Labeler NameSolco Healthcare US LLC
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 43547-258-01

10 mL in 1 BOTTLE, PLASTIC (43547-258-01)
Marketing Start Date2010-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43547-258-01 [43547025801]

Fluorouracil SOLUTION
Marketing CategoryNDA
Application NumberNDA016831
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-06-01
Marketing End Date2018-07-01
Inactivation Date2019-10-21
Reactivation Date2020-04-03

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL50 mg/mL

OpenFDA Data

SPL SET ID:e4acd6ec-d981-4756-9c59-7ee981be9c12
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310379
  • 310380
  • Pharmacological Class

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

    Medicade Reported Pricing

    43547025801 FLUOROURACIL 5% TOP SOLUTION

    Pricing Unit: ML | Drug Type:

    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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