NDC 63323-117

Fluorouracil

Fluorouracil

Fluorouracil is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Fluorouracil.

Product ID63323-117_08d76455-44fc-48f6-8b78-ddf0f08cc758
NDC63323-117
Product TypeHuman Prescription Drug
Proprietary NameFluorouracil
Generic NameFluorouracil
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2000-07-12
Marketing CategoryANDA / ANDA
Application NumberANDA040279
Labeler NameFresenius Kabi USA, LLC
Substance NameFLUOROURACIL
Active Ingredient Strength50 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-117-59

1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-117-59) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
Marketing Start Date2000-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-117-58 [63323011758]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-12

NDC 63323-117-59 [63323011759]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-12

NDC 63323-117-69 [63323011769]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-12

NDC 63323-117-19 [63323011719]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-12

NDC 63323-117-41 [63323011741]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-20

NDC 63323-117-01 [63323011701]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-19

NDC 63323-117-20 [63323011720]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-01-02

NDC 63323-117-28 [63323011728]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-12

NDC 63323-117-18 [63323011718]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-12

NDC 63323-117-31 [63323011731]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-20

NDC 63323-117-68 [63323011768]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-12

NDC 63323-117-10 [63323011710]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040279
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-01-02

NDC 63323-117-43 [63323011743]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-20

NDC 63323-117-51 [63323011751]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-12

NDC 63323-117-61 [63323011761]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-07-12

NDC 63323-117-00 [63323011700]

Fluorouracil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-19

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL50 mg/mL

OpenFDA Data

SPL SET ID:b4328ae3-f48f-40b1-9719-1c1aced7c734
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 239177
  • 1791736
  • 1791701

    • 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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