MedPath

Fomepizole

Rx only Sterile Caution : Must be diluted prior to use. Do not use polycarbonate syringes or polycarbonate-containing needles (including polycarbonate filter needles) with fomepizole injection.

Approved
Approval ID

256910fe-91f2-48f6-b0b4-55edc52dacd4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 10, 2023

Manufacturers
FDA

Zydus Pharmaceuticals USA Inc.

DUNS: 156861945

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fomepizole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70710-1478
Application NumberANDA078537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fomepizole
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 10, 2023
FDA Product Classification

INGREDIENTS (1)

FOMEPIZOLEActive
Quantity: 1 g in 1 mL
Code: 83LCM6L2BY
Classification: ACTIB

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 10/27/2022

DESCRIPTION

Fomepizole Injection is a competitive inhibitor of alcohol dehydrogenase. The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C4H6N2 and a molecular weight of 82.1. The structural formula is:

Image

It is a clear to yellow liquid at room temperature. Its melting point is 25°C(77°F) and it may present as solid form at room temperature. Fomepizole is soluble in water and very soluble in ethanol, diethyl ether, and chloroform. Each vial contains 1.5 mL (1 g/mL) of fomepizole.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Fomepizole - FDA Drug Approval Details