NDC 0187-3204

Efudex

Fluorouracil

Efudex is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Americas, Inc.. The primary component is Fluorouracil.

Product ID0187-3204_2643cefd-80e5-4009-a211-f8ec91868126
NDC0187-3204
Product TypeHuman Prescription Drug
Proprietary NameEfudex
Generic NameFluorouracil
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date1970-07-29
Marketing CategoryNDA / NDA
Application NumberNDA016831
Labeler NameBausch Health Americas, Inc.
Substance NameFLUOROURACIL
Active Ingredient Strength2 g/40g
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0187-3204-47

1 TUBE in 1 CARTON (0187-3204-47) > 40 g in 1 TUBE
Marketing Start Date1970-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-3204-47 [00187320447]

Efudex CREAM
Marketing CategoryNDA
Application NumberNDA016831
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1970-07-29

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL2 g/40g

OpenFDA Data

SPL SET ID:35de1c1c-bef5-46c5-b6f8-ea032147411c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 105583
  • 213045
  • 310379
  • 213517
  • 213268
  • 310380

    • Pharmacological Class

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

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

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

    Trademark Results [Efudex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EFUDEX
    EFUDEX
    78093291 2621546 Live/Registered
    VALEANT PHARMACEUTICALS NORTH AMERICA LLC
    2001-11-14
    EFUDEX
    EFUDEX
    72318046 0885319 Dead/Expired
    HOFFMANN-LA ROCHE INC.
    1969-01-31
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