Data / Drug companies / Tizanidine hydrochloride
Tizanidine hydrochloride: 25 companies and 66 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Tizanidine hydrochloride is listed in the FDA National Drug Code Directory by 25 companies, with 66 products in commercial distribution. 54 of the products (81.8%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; capsule, gelatin coated; tablet, and the newest product started marketing on September 16, 2025.
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- Companies listing it
- 25
- Products
- 66
- Generic (ANDA) products
- 54 (81.8%)
- Application numbers
- 13
- Routes
- Oral
- Brand names
- Zanaflex, Ontralfy
- openFDA record search
- api.fda.gov
Companies that list tizanidine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Advagen Pharma Ltd | 4 | capsule | Generic drugs (ANDA) | August 28, 2025 |
| Covis Pharma US, Inc | 4 | capsule; tablet | New drug applications (NDA) | August 1, 2018 |
| Legacy Pharma USA Inc. | 4 | capsule; tablet | New drug applications (NDA) | August 1, 2018 |
| Actavis Pharma, Inc. | 3 | capsule, gelatin coated | Authorized generics (NDA) | February 6, 2012 |
| Alembic Pharmaceuticals Inc. | 3 | capsule | Generic drugs (ANDA) | January 15, 2020 |
| Alembic Pharmaceuticals Limited | 3 | capsule | Generic drugs (ANDA) | January 15, 2020 |
| Apotex Corp. | 3 | capsule, gelatin coated | Generic drugs (ANDA) | February 6, 2012 |
| Asclemed USA, Inc. | 3 | capsule | Generic drugs (ANDA) | March 29, 2019 |
| Aurobindo Pharma Limited | 3 | capsule | Generic drugs (ANDA) | March 24, 2020 |
| Bryant Ranch Prepack | 3 | capsule | Generic drugs (ANDA) | May 27, 2020 |
| Cadila Pharmaceuticals Limited | 3 | capsule | Generic drugs (ANDA) | December 29, 2017 |
| Ingenus Pharmaceuticals, LLC | 3 | capsule | Generic drugs (ANDA) | March 20, 2019 |
| Kanchan Healthcare Inc | 3 | capsule | Generic drugs (ANDA) | December 29, 2017 |
| Modavar Pharmaceuticals LLC | 3 | capsule | Generic drugs (ANDA) | December 29, 2017 |
| PD-Rx Pharmaceuticals, Inc. | 3 | capsule | Generic drugs (ANDA) | May 27, 2020 |
| Preferred Pharmaceuticals Inc. | 3 | capsule | Generic drugs (ANDA) | December 9, 2024 |
| Zydus Lifesciences Limited | 3 | capsule | Generic drugs (ANDA) | April 27, 2017 |
| Zydus Pharmaceuticals USA Inc. | 3 | capsule | Generic drugs (ANDA) | April 27, 2017 |
| Advanced Rx of Tennessee, LLC | 2 | capsule | Generic drugs (ANDA) | January 20, 2025 |
| Trifluent Pharma, LLC | 2 | capsule | Generic drugs (ANDA) | September 16, 2025 |
| AvKARE | 1 | capsule, gelatin coated | Generic drugs (ANDA) | June 20, 2014 |
| Direct RX | 1 | tablet | Generic drugs (ANDA) | January 1, 2014 |
| Quality Care Products LLC | 1 | tablet | Generic drugs (ANDA) | November 23, 2010 |
| Rosemont Pharmaceuticals LLC | 1 | solution | New drug applications (NDA) | March 31, 2025 |
| St. Mary's Medical Park Pharmacy | 1 | capsule | Generic drugs (ANDA) | March 20, 2019 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 54 | 81.8% |
| Capsule, gelatin coated | 7 | 10.6% |
| Tablet | 4 | 6.1% |
| Solution | 1 | 1.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 54 | 81.8% |
| New drug applications (NDA) | 9 | 13.6% |
| Authorized generics (NDA) | 3 | 4.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Central alpha-2 Adrenergic Agonist | 66 |
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.