NDC 68475-510

Fomepizole

Fomepizole

Fomepizole is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Navinta Llc. The primary component is Fomepizole.

Product ID68475-510_6a1a61ce-ff06-4184-986c-97ac1af99134
NDC68475-510
Product TypeHuman Prescription Drug
Proprietary NameFomepizole
Generic NameFomepizole
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-05-08
Marketing CategoryANDA / ANDA
Application NumberANDA078537
Labeler NameNavinta LLC
Substance NameFOMEPIZOLE
Active Ingredient Strength1 g/mL
Pharm ClassesAntidote [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68475-510-01

1 VIAL in 1 CARTON (68475-510-01) > 1.5 mL in 1 VIAL
Marketing Start Date2021-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68475-510-01 [68475051001]

Fomepizole INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078537
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-08

Drug Details

Active Ingredients

IngredientStrength
FOMEPIZOLE1 g/mL

OpenFDA Data

SPL SET ID:6fed6052-f159-46d6-8be1-31e18a7ba918
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310414
  • UPC Code
  • 0368475510012
  • 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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