NDC 0187-5200

Carac

Fluorouracil

Carac is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Fluorouracil.

Product ID0187-5200_8fb0477d-5bf9-482f-9b73-e19cdced9571
NDC0187-5200
Product TypeHuman Prescription Drug
Proprietary NameCarac
Generic NameFluorouracil
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-06-28
Marketing CategoryNDA / NDA
Application NumberNDA020985
Labeler NameBausch Health US LLC
Substance NameFLUOROURACIL
Active Ingredient Strength5 mg/g
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0187-5200-30

1 TUBE in 1 CARTON (0187-5200-30) > 30 g in 1 TUBE
Marketing Start Date2013-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-5200-30 [00187520030]

Carac CREAM
Marketing CategoryNDA
Application NumberNDA020985
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2013-06-28

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL5 mg/g

OpenFDA Data

SPL SET ID:6795f2b1-1381-4a4f-ad34-2c28ebd1cfaf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 284539
  • 284191

    • Pharmacological Class

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

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

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

    Trademark Results [Carac]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CARAC
    CARAC
    97383335 not registered Live/Pending
    Wenzhou Dajieni Electronic Commerce Co., Ltd.
    2022-04-27
    CARAC
    CARAC
    78034172 2701399 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    2000-11-07
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