NDC 70710-1478

Fomepizole

Fomepizole

Fomepizole is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Fomepizole.

Product ID70710-1478_3f024d25-7f96-4a69-b413-535b53b1e0d6
NDC70710-1478
Product TypeHuman Prescription Drug
Proprietary NameFomepizole
Generic NameFomepizole
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-10-05
Marketing CategoryANDA / ANDA
Application NumberANDA078537
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NameFOMEPIZOLE
Active Ingredient Strength1 g/mL
Pharm ClassesAntidote [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70710-1478-1

1 VIAL in 1 CARTON (70710-1478-1) > 1.5 mL in 1 VIAL
Marketing Start Date2021-03-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70710-1478-1 [70710147801]

Fomepizole INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078537
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-09-10

Drug Details

Active Ingredients

IngredientStrength
FOMEPIZOLE1 g/mL

OpenFDA Data

SPL SET ID:256910fe-91f2-48f6-b0b4-55edc52dacd4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310414
  • UPC Code
  • 0370710147815
  • 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

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