Drug
Who makes tizanidine hydrochloride?
25 companies list tizanidine hydrochloride as a human prescription drug, including under the names Ontralfy, Zanaflex. Forms: capsule; capsule, gelatin coated; solution; tablet. Routes: oral.
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 tizanidine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | capsule | ANDAANDA213223 | 6 | 7 |
| Legacy Pharma USA Inc.United States | capsule; tablet | NDANDA020397, NDA021447 | 4 | 1 |
| Advagen Pharma Limited | capsule | ANDAANDA213798 | 4 | 0 |
| Covis Pharma US, Inc | capsule; tablet | NDANDA020397, NDA021447 | 4 | 0 |
| Zydus Lifesciences LimitedIndia | capsule | ANDAANDA208622 | 3 | 12 |
| Apotex Inc.Canada | capsule, gelatin coated | ANDAANDA078868 | 3 | 6 |
| Cadila Pharmaceuticals LimitedIndia | capsule | ANDAANDA210021 | 3 | 3 |
| Nivagen Pharmaceuticals LLCUnited States | capsule | ANDAANDA210021 | 3 | 2 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | capsule | ANDAANDA212196 | 3 | 1 |
| Actavis LLCUnited States | capsule, gelatin coated | NDA AUTHORIZED GENERICNDA021447 | 3 | 1 |
| Bryant Ranch PrepackUnited States | capsule | ANDAANDA210267, ANDA213798 | 3 | 1 |
| Modavar Pharmaceuticals LLCUnited States | capsule | ANDAANDA210021 | 3 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | capsule | ANDAANDA213798 | 3 | 1 |
| Preferred Pharmaceuticals Inc.United States | capsule | ANDAANDA210267, ANDA213798 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | capsule | ANDAANDA208622 | 3 | 1 |
| Ingenus Pharmaceuticals, LLC | capsule | ANDAANDA210267 | 3 | 0 |
| Kanchan Healthcare Inc | capsule | ANDAANDA210021 | 3 | 0 |
| Aurobindo Pharma LimitedIndia | capsule | ANDAANDA213544 | 2 | 6 |
| Trifluent Pharma LLCUnited States | capsule | ANDAANDA213798 | 2 | 1 |
| Advanced Rx of Tennessee, LLC | capsule | ANDAANDA210267, ANDA213798 | 2 | 0 |
| Rosemont Pharmaceuticals LimitedUnited Kingdom | solution | NDANDA216190 | 1 | 1 |
| St. Mary's Medical Park PharmacyUnited States | capsule | ANDAANDA210267 | 1 | 1 |
| AvKARE | capsule, gelatin coated | ANDAANDA078868 | 1 | 0 |
| Quality Care Products, LLC | tablet | ANDAANDA076286 | 1 | 0 |
| TIZANIDINE HYDROCHLORIDE | tablet | ANDAANDA091283 | 1 | 0 |
Bulk ingredient listings
- CZECH-GEN, a.s.Czechia · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Mylan Pharmaceuticals, Inc. · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Symed Labs Limited · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- Viyash Scientific LimitedIndia · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
2 unexpired patents list tizanidine hydrochloride as the active ingredient, expiring between May 2042 and May 2042. Application holder: FIDELITY BIOPHARMA CO USA.
Enquiry
Common questions
- Who makes tizanidine hydrochloride?
- 25 companies list tizanidine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Legacy Pharma USA Inc., Advagen Pharma Limited, Covis Pharma US, Inc, Zydus Lifesciences Limited. 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 Ontralfy?
- 21 companies list tizanidine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies tizanidine hydrochloride active ingredient?
- 10 companies list tizanidine hydrochloride as a bulk ingredient, including CZECH-GEN, a.s., Dr. Reddy's Laboratories Limited, MEDISCA Inc., Mylan Pharmaceuticals, Inc..