Drug
Who makes fomepizole?
6 companies list fomepizole as a human prescription drug. Forms: injection; injection, solution. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing fomepizole
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| American Regent, Inc.United States | injection, solution | ANDAANDA078368 | 1 | 5 |
| GLAND PHARMA LIMITEDIndia | injection | ANDAANDA216791 | 1 | 4 |
| Navinta LLCUnited States | injection, solution | ANDAANDA078537 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | injection, solution | ANDAANDA078537 | 1 | 1 |
| Mylan Institutional Inc. | injection, solution | ANDAANDA078639 | 1 | 0 |
| Sagent Pharmaceuticals | injection | ANDAANDA216791 | 1 | 0 |
Bulk ingredient listings
- APOTHECON PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- SERATECFrance · 1 NDC
- Sterling Pharmaceutical Services, LLCUnited States · 1 NDC
Orange Book patents
1 unexpired patent lists fomepizole as the active ingredient, expiring between Jun 2027 and Jun 2027. Application holder: PAR PHARMACEUTICAL INC.
Enquiry
Common questions
- Who makes fomepizole?
- 6 companies list fomepizole as a human prescription drug in the openFDA NDC Directory, led by American Regent, Inc., GLAND PHARMA LIMITED, Navinta LLC, Zydus Pharmaceuticals USA Inc., Mylan Institutional Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic fomepizole?
- 6 companies list fomepizole under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies fomepizole active ingredient?
- 4 companies list fomepizole as a bulk ingredient, including APOTHECON PHARMACEUTICALS PRIVATE LIMITED, Cohance Lifesciences Limited, SERATEC, Sterling Pharmaceutical Services, LLC.