Active ingredient
Fomepizole
7 finished FDA listings contain Fomepizole as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FOMEPIZOLE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 6
- Strengths listed
- 1 g/ml · 1.5 g/1.5ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 15226
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 078368 | AM REGENT | 2007-12-14 | 2 |
| ANDA 078639 | MYLAN INSTITUTIONAL | 2008-03-03 | 1 |
| ANDA 078537 | NAVINTA LLC | 2008-03-06 | 2 |
| ANDA 216791 | GLAND | 2023-07-06 | 2 |
Official labeling on DailyMed
- FOMEPIZOLE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] · version 8 · 2025-11-21
- FOMEPIZOLE INJECTION, SOLUTION [NAVINTA LLC] · version 8 · 2024-12-23
- FOMEPIZOLE INJECTION [SAGENT PHARMACEUTICALS] · version 2 · 2023-12-29
- FOMEPIZOLE INJECTION [GLAND PHARMA LIMITED] · version 4 · 2023-07-11
- FOMEPIZOLE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 7 · 2021-05-11
- FOMEPIZOLE INJECTION, SOLUTION [AMERICAN REGENT, INC.] · version 4 · 2021-01-26
- FOMEPIZOLE INJECTION, SOLUTION [AMERICAN REGENT, INC.] · version 4 · 2021-01-26
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.