NDC 68083-293

Fluorouracil

Fluorouracil

Fluorouracil is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Fluorouracil.

Product ID68083-293_55f66165-9ec7-434f-9c41-34ec75fda2a7
NDC68083-293
Product TypeHuman Prescription Drug
Proprietary NameFluorouracil
Generic NameFluorouracil
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA210124
Labeler NameGland Pharma Limited
Substance NameFLUOROURACIL
Active Ingredient Strength50 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-293-01

1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-293-01) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
Marketing Start Date2018-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-293-01 [68083029301]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210124
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-05

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL50 mg/mL

OpenFDA Data

SPL SET ID:ea3497db-23b9-4ace-9a6f-b54853d04a82
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 239177
    • UPC Code
  • 0368083293017
  • 0368083292010

    • 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" 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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