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

6fed6052-f159-46d6-8be1-31e18a7ba918

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 31, 2023

Manufacturers
FDA

Navinta LLC

DUNS: 130443810

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 Code68475-510
Application NumberANDA078537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fomepizole
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 31, 2023
FDA Product Classification

INGREDIENTS (1)

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/9/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

vial

carton

vial label

carton label

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Fomepizole - FDA Drug Approval Details