Data / Drug companies / Tinidazole
Tinidazole: 7 companies and 13 products in the FDA NDC directory
Tinidazole is listed in the FDA National Drug Code Directory by 7 companies, with 13 products in commercial distribution. 10 of the products (76.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, and the newest product started marketing on August 18, 2026.
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- Companies listing it
- 7
- Products
- 13
- Generic (ANDA) products
- 10 (76.9%)
- Application numbers
- 4
- Routes
- Oral
- Brand names
- Tindazole, Tindamax
- openFDA record search
- api.fda.gov
Companies that list tinidazole
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Chartwell RX, LLC | 2 | tablet, film coated | Generic drugs (ANDA) | April 30, 2012 |
| Edenbridge Pharmaceuticals LLC. | 2 | tablet | Generic drugs (ANDA) | December 20, 2019 |
| Lupin Pharmaceuticals,Inc. | 2 | tablet | Generic drugs (ANDA) | April 30, 2012 |
| Mission Pharmacal Company | 2 | tablet, film coated | New drug applications (NDA) | May 17, 2004 |
| Remedyrepack Inc. | 2 | tablet, film coated; tablet | Generic drugs (ANDA) | August 18, 2026 |
| Rising Pharma Holdings, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | October 9, 2013 |
| BioComp Pharma, Inc. | 1 | tablet, film coated | Authorized generics (NDA) | March 20, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 8 | 61.5% |
| Tablet | 5 | 38.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 10 | 76.9% |
| New drug applications (NDA) | 2 | 15.4% |
| Authorized generics (NDA) | 1 | 7.7% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nitroimidazole Antimicrobial | 13 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.