Drug
Who makes metronidazole?
61 companies list metronidazole as a human prescription drug, including under the names Flagyl, Noritate, Nuvessa, Vandazole, Vagizole. Forms: capsule; cream; gel; injection, solution; lotion; solution; tablet; tablet, film coated; tablet, film coated, extended release. Routes: intravenous, oral, topical, vaginal.
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 metronidazole
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | cream; tablet; tablet, film coated | ANDAANDA070027, ANDA070033, ANDA070772 | 18 | 1 |
| RemedyRepack, IncUnited States | gel; tablet; tablet, film coated | ANDAANDA070027, ANDA070033, ANDA203458 | 14 | 1 |
| Alembic Pharmaceuticals LimitedIndia | capsule; gel; tablet; tablet, film coated, extended release | ANDAANDA079065, ANDA079067, ANDA090222 | 11 | 7 |
| International Medication Systems, Ltd.United States | gel; tablet; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA203458, ANDA203974, ANDA211786 | 9 | 3 |
| NuCare Pharmaceuticals,Inc.United States | tablet; tablet, film coated | ANDAANDA079067, ANDA203458, ANDA203974 | 9 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet; tablet, film coated | ANDAANDA079067, ANDA203458, ANDA206560 | 5 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | gel; injection, solution | ANDAANDA077819, ANDA204651, ANDA212435 | 4 | 13 |
| Zydus Lifesciences LimitedIndia | cream; gel; tablet | ANDAANDA206560, ANDA217128, ANDA220095 | 4 | 12 |
| Aurobindo Pharma LimitedIndia | cream; gel; tablet | ANDAANDA203974, ANDA218941, ANDA219295 | 4 | 6 |
| Preferred Pharmaceuticals Inc.United States | cream; tablet; tablet, film coated | ANDAANDA203458, ANDA206560, ANDA217128 | 4 | 1 |
| Cosette Pharmaceuticals, Inc. | cream; gel | ANDAANDA077549, ANDA078178, ANDA216323 | 4 | 0 |
| Method Pharmaceuticals, LLC. | tablet | ANDAANDA070772 | 4 | 0 |
| Viona Pharmaceuticals Inc. | cream; gel; tablet | ANDAANDA206560, ANDA217128, ANDA220095 | 4 | 0 |
| Mayne Pharma International Pty Ltd.Australia | cream; gel; lotion | NDA AUTHORIZED GENERICNDA020531, NDA020901, NDA021789 | 3 | 1 |
| Northwind Health Company, LLCUnited States | tablet | ANDAANDA205245, ANDA206560 | 3 | 1 |
| Proficient Rx LPUnited States | tablet; tablet, film coated | ANDAANDA070027, ANDA070033, ANDA203458 | 3 | 1 |
| RedPharm DrugUnited States | gel; tablet; tablet, film coated | ANDAANDA070033, ANDA077819, ANDA203458 | 3 | 1 |
| Chartwell RX, LLC. | capsule; tablet | ANDAANDA076522, ANDA205245 | 3 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA070772, ANDA205245 | 2 | 34 |
| Baxter Healthcare CorporationUnited States | injection, solution | NDANDA018657 | 2 | 16 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet | ANDAANDA070027, ANDA070033 | 2 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA070772 | 2 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet, film coated | ANDAANDA203458 | 2 | 5 |
| Cadila Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA209794 | 2 | 3 |
| Fougera Pharmaceuticals, LLCUnited States | cream; lotion | ANDAANDA076408, ANDA077197 | 2 | 2 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | ANDAANDA206560 | 2 | 1 |
| Coupler LLCUnited States | tablet, film coated | ANDAANDA203458 | 2 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA070772 | 2 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | tablet | ANDAANDA205245 | 2 | 1 |
| PharmPak, Inc.United States | tablet, film coated | ANDAANDA203458 | 2 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet | ANDAANDA203974 | 2 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet; tablet, film coated | ANDAANDA203458, ANDA206560 | 2 | 1 |
| Amici Pharmaceuticals, LLC. | tablet | ANDAANDA070772 | 2 | 0 |
| AvPAK | tablet | ANDAANDA079067 | 2 | 0 |
| BluePoint Laboratories Inc. | tablet, film coated | ANDAANDA203458 | 2 | 0 |
| Kanchan Healthcare Inc | tablet, film coated | ANDAANDA209794 | 2 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA205245 | 2 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | gel | ANDAANDA215794 | 1 | 9 |
| Hospira, Inc.United States | injection, solution | ANDAANDA206191 | 1 | 7 |
| Encube Ethicals LimitedIndia | gel | ANDAANDA215610 | 1 | 5 |
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA212435 | 1 | 4 |
| B. Braun US Pharmaceutical Manufacturing LLCUnited States | solution | NDANDA018900 | 1 | 3 |
| Padagis Israel Pharmaceuticals LtdUnited States | gel | ANDAANDA211786 | 1 | 2 |
| Amneal Ireland LimitedIreland | injection, solution | ANDAANDA217665 | 1 | 1 |
| Bausch Health US, LLCCanada | cream | NDANDA020743 | 1 | 1 |
| Civica, Inc. dba CivicaRxUnited States | injection, solution | NDANDA018657 | 1 | 1 |
| Direct RxUnited States | tablet, film coated | ANDAANDA203458 | 1 | 1 |
| Henry Schein, Inc.United States | injection, solution | ANDAANDA206191 | 1 | 1 |
| Saptalis Pharmaceuticals, LLCUnited States | gel | ANDAANDA216750 | 1 | 1 |
| Solaris Pharma CorporationUnited States | gel | ANDAANDA213648 | 1 | 1 |
| Exeltis USA, Inc. | gel | NDANDA205223 | 1 | 0 |
| Northstar Rx, LLC, | gel | ANDAANDA215794 | 1 | 0 |
| Oceanside Pharmaceuticals. | cream | NDANDA020743 | 1 | 0 |
| Pfizer Laboratories Div Pfizer Inc | capsule | NDANDA020334 | 1 | 0 |
| Prasco Laboratories | cream | NDA AUTHORIZED GENERICNDA020531 | 1 | 0 |
| Quality Care Products, LLC | tablet, film coated | ANDAANDA203458 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA206191 | 1 | 0 |
| Sportpharm LLC | tablet | ANDAANDA206560 | 1 | 0 |
| Upsher-Smith Laboratories, Inc. | gel | NDANDA021806 | 1 | 0 |
| WG Critical Care, LLC. | injection, solution | ANDAANDA206191 | 1 | 0 |
| iNutrition LLC | gel | ANDAANDA213648 | 1 | 0 |
Bulk ingredient listings
- Corden Pharma Bergamo SpAItaly · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- SYNFINE DRUGS PRIVATE LIMITEDIndia · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
Orange Book patents
9 unexpired patents list metronidazole as the active ingredient, expiring between Feb 2028 and Oct 2039. Application holders: ALEMBIC THERAPEUTICS LLC, SAPTALIS PHARMACEUTICALS LLC.
Enquiry
Common questions
- Who makes metronidazole?
- 61 companies list metronidazole as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, RemedyRepack, Inc, Alembic Pharmaceuticals Limited, International Medication Systems, Ltd., NuCare Pharmaceuticals,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 Flagyl?
- 51 companies list metronidazole under an abbreviated new drug application (ANDA), the application type used for generics, and 8 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies metronidazole active ingredient?
- 7 companies list metronidazole as a bulk ingredient, including Corden Pharma Bergamo SpA, Kalchem International Inc., MEDISCA Inc., Professional Compounding Centers of America dba PCCA.