NDC 0378-8078

Fluorouracil Cream

Fluorouracil

Fluorouracil Cream is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fluorouracil.

Product ID0378-8078_2e7939fa-eadb-459e-be03-99b74273b393
NDC0378-8078
Product TypeHuman Prescription Drug
Proprietary NameFluorouracil Cream
Generic NameFluorouracil
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2019-07-03
Marketing CategoryNDA / NDA
Application NumberNDA020985
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFLUOROURACIL
Active Ingredient Strength5 mg/g
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-8078-49

1 TUBE in 1 CARTON (0378-8078-49) > 30 g in 1 TUBE
Marketing Start Date2020-08-28
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL5 mg/g

OpenFDA Data

SPL SET ID:2e7939fa-eadb-459e-be03-99b74273b393
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 284191
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0378-8078Fluorouracil Creamfluorouracil
    0703-3015AdrucilFluorouracil
    0703-3018AdrucilFluorouracil
    0703-3019AdrucilFluorouracil
    0187-5200Caracfluorouracil
    0187-3204EfudexFluorouracil
    16110-812Fluoroplexfluorouracil
    0378-4791FluorouracilFluorouracil
    16714-178FluorouracilFluorouracil
    16729-276FluorouracilFluorouracil
    16729-542FluorouracilFluorouracil
    21695-829FLUOROURACILfluorouracil
    25021-215fluorouracilfluorouracil

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