NDC 0517-0710

fomepizole

Fomepizole

fomepizole is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Fomepizole.

Product ID0517-0710_004af6c3-20cf-4bbf-aac7-41102ee3252c
NDC0517-0710
Product TypeHuman Prescription Drug
Proprietary Namefomepizole
Generic NameFomepizole
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-07-16
Marketing CategoryANDA / ANDA
Application NumberANDA078368
Labeler NameAmerican Regent, Inc.
Substance NameFOMEPIZOLE
Active Ingredient Strength1 g/mL
Pharm ClassesAntidote [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0517-0710-01

1 VIAL in 1 CARTON (0517-0710-01) > 1.5 mL in 1 VIAL
Marketing Start Date2018-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-0710-01 [00517071001]

fomepizole INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078368
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-07-16

Drug Details

Active Ingredients

IngredientStrength
FOMEPIZOLE1 g/mL

OpenFDA Data

SPL SET ID:82dc2920-af7f-4e43-9f6d-8877a71884cd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310414
  • Pharmacological Class

    • Antidote [EPC]

    NDC Crossover Matching brand name "fomepizole" or generic name "Fomepizole"

    NDCBrand NameGeneric Name
    0517-0710fomepizolefomepizole
    0781-3182fomepizolefomepizole
    67457-211FomepizoleFomepizole
    68475-510FomepizoleFomepizole
    70710-1478FomepizoleFomepizole
    46129-200Antizolfomepizole

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