NDC 0703-3015

Adrucil

Fluorouracil

Adrucil is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Fluorouracil.

Product ID0703-3015_869e2522-b36f-4583-9ce2-e2d520f3e2c3
NDC0703-3015
Product TypeHuman Prescription Drug
Proprietary NameAdrucil
Generic NameFluorouracil
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2003-10-01
Marketing End Date2020-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA040333
Labeler NameTeva Parenteral Medicines, Inc.
Substance NameFLUOROURACIL
Active Ingredient Strength50 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN

Packaging

NDC 0703-3015-13

10 VIAL, SINGLE-DOSE in 1 CARTON (0703-3015-13) > 10 mL in 1 VIAL, SINGLE-DOSE (0703-3015-11)
Marketing Start Date2003-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0703-3015-11 [00703301511]

Adrucil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040333
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-10-01
Marketing End Date2020-10-31

NDC 0703-3015-13 [00703301513]

Adrucil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040333
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-10-01
Marketing End Date2020-10-31

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL50 mg/mL

OpenFDA Data

SPL SET ID:e0794add-67a7-4308-93e9-f889472716cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1791703
  • 1791701
  • Pharmacological Class

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

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

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

    Trademark Results [Adrucil]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ADRUCIL
    ADRUCIL
    73146733 1100532 Live/Registered
    ADRIA LABORATORIES INC.
    1977-10-31

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