NDC 0378-4791

Fluorouracil

Fluorouracil

Fluorouracil 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 ID0378-4791_267927b3-e535-4b22-90ab-33e36e1fa980
NDC0378-4791
Product TypeHuman Prescription Drug
Proprietary NameFluorouracil
Generic NameFluorouracil
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-07-23
Marketing CategoryNDA / NDA
Application NumberNDA016831
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 Through2021-12-31

Packaging

NDC 0378-4791-06

1 TUBE in 1 CARTON (0378-4791-06) > 40 g in 1 TUBE
Marketing Start Date2013-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4791-06 [00378479106]

Fluorouracil CREAM
Marketing CategoryNDA
Application NumberNDA016831
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2013-07-23

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL5 mg/g

OpenFDA Data

SPL SET ID:744737c5-0d96-4214-82ab-6cff016b1ea0
Manufacturer
UNII
UPC Code
  • 0303784791066
  • 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
    16729-276FluorouracilFluorouracil
    16729-542FluorouracilFluorouracil
    21695-829FLUOROURACILfluorouracil
    25021-215fluorouracilfluorouracil
    43547-258FluorouracilFluorouracil
    43547-259FluorouracilFluorouracil
    50090-4264FluorouracilFluorouracil
    68001-266FluorouracilFluorouracil
    68083-293FluorouracilFluorouracil
    68083-292FluorouracilFluorouracil
    68083-269FluorouracilFluorouracil
    68083-270FluorouracilFluorouracil
    51672-4063FluorouracilFluorouracil
    51672-4062FluorouracilFluorouracil
    51672-4118FluorouracilFluorouracil
    52549-4118FluorouracilFluorouracil
    63323-117FluorouracilFluorouracil
    66758-044FluorouracilFluorouracil
    66758-054FluorouracilFluorouracil
    66530-249FLUOROURACILFLUOROURACIL
    66530-258FluorouracilFluorouracil
    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
    28105-421TOLAKFLUOROURACIL

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