NDC 16729-276

Fluorouracil

Fluorouracil

Fluorouracil is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare, Inc.. The primary component is Fluorouracil.

Product ID16729-276_492ff0cd-24fe-0b4d-e054-00144ff8d46c
NDC16729-276
Product TypeHuman Prescription Drug
Proprietary NameFluorouracil
Generic NameFluorouracil
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-03-14
Marketing CategoryANDA / ANDA
Application NumberANDA040743
Labeler NameAccord Healthcare, Inc.
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 16729-276-11

1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16729-276-11) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
Marketing Start Date2014-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-276-05 [16729027605]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040743
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-02-28

NDC 16729-276-38 [16729027638]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040798
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-03-14

NDC 16729-276-68 [16729027668]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040743
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-03-25

NDC 16729-276-03 [16729027603]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040743
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-02-28

NDC 16729-276-67 [16729027667]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040743
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-03-14

NDC 16729-276-11 [16729027611]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040798
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-03-14

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL50 mg/mL

OpenFDA Data

SPL SET ID:8eff167f-203a-4a81-b2fc-d8773bc3555e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 239177
  • 1791736
  • 1791701
  • UPC Code
  • 0316729276115
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.