Drug
Who makes cyclobenzaprine hydrochloride?
52 companies list cyclobenzaprine hydrochloride as a human prescription drug, including under the names AMRIX, TONMYA, Fexmid. Forms: capsule, extended release; tablet; tablet, film coated; tablet, orally disintegrating. Routes: oral, sublingual.
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 cyclobenzaprine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule, extended release; tablet; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA077563, ANDA077797, ANDA078643 | 21 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | capsule, extended release; tablet, film coated | ANDAANDA071611, ANDA077797, ANDA078643 | 18 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet, film coated | ANDAANDA071611, ANDA078643, ANDA208170 | 15 | 1 |
| RemedyRepack, IncUnited States | capsule, extended release; tablet; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA078643, ANDA091281, ANDA208170 | 14 | 1 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA078722, ANDA208170, ANDA213324 | 11 | 3 |
| Proficient Rx LPUnited States | capsule, extended release; tablet, film coated | ANDAANDA077797, ANDA078048, ANDA078218 | 11 | 1 |
| Preferred Pharmaceuticals Inc.United States | capsule, extended release; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA077563, ANDA078643, ANDA078722 | 10 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA077797, ANDA078048, ANDA208170 | 7 | 1 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule, extended release; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA071611, NDA021777 | 5 | 6 |
| Northwind Health Company, LLCUnited States | tablet, film coated | ANDAANDA078643, ANDA208170 | 5 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet; tablet, film coated | ANDAANDA078643, ANDA218936 | 5 | 1 |
| Advanced Rx of Tennessee, LLC | capsule, extended release; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA077563, ANDA077797, ANDA091281 | 5 | 0 |
| Sportpharm LLC | tablet, film coated | ANDAANDA208170, ANDA213324 | 5 | 0 |
| Amneal Pharmaceuticals of New York, LLCIndia | capsule, extended release; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA078218, NDA021777 | 4 | 14 |
| Direct RxUnited States | capsule, extended release; tablet, film coated | ANDAANDA078722, ANDA091281, ANDA208170 | 4 | 1 |
| PHOENIX RX LLCUnited States | capsule, extended release; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA091281, ANDA208170, ANDA213324 | 4 | 1 |
| RedPharm DrugUnited States | tablet, film coated | ANDAANDA078643, ANDA208170, ANDA213324 | 4 | 1 |
| Alembic Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA078218 | 3 | 7 |
| Unichem Laboratories Limited, IndiaIndia | tablet, film coated | ANDAANDA213324 | 3 | 5 |
| Coupler LLCUnited States | tablet, film coated | ANDAANDA077563, ANDA208170 | 3 | 1 |
| HAWAII REPACK INCUnited States | tablet, film coated | ANDAANDA208170 | 3 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet, film coated | ANDAANDA208170, ANDA213324 | 3 | 1 |
| Advagen Pharma Limited | tablet, film coated | ANDAANDA208170 | 3 | 0 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | ANDAANDA077563, ANDA077797, ANDA078048 | 3 | 0 |
| Jubilant Cadista Pharmaceuticals Inc. | tablet, film coated | ANDAANDA077563 | 3 | 0 |
| Northstar Rx, LLC, | tablet, film coated | ANDAANDA208170 | 3 | 0 |
| TruPharma LLC. | tablet, film coated | ANDAANDA208170 | 3 | 0 |
| Macleods Pharmaceuticals LimitedIndia | capsule, extended release | ANDAANDA207314 | 2 | 5 |
| KVK-TECH, INC.United States | tablet, film coated | ANDAANDA078048 | 2 | 2 |
| Amneal Ireland LimitedIreland | tablet, film coated | ANDAANDA078218 | 2 | 1 |
| Medcore llcUnited States | tablet, film coated | ANDAANDA208170 | 2 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet; tablet, film coated | ANDAANDA213324, ANDA218936 | 2 | 1 |
| QPharma IncUnited States | tablet, film coated | ANDAANDA078643, ANDA208170 | 2 | 1 |
| Cephalon, Inc. | capsule, extended release | NDANDA021777 | 2 | 0 |
| DirectRx | tablet, film coated | ANDAANDA208170, ANDA213324 | 2 | 0 |
| Doc Rx | capsule, extended release; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA077563, NDA021777 | 2 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA078643 | 2 | 0 |
| Solco healthcare U.S., LLC | tablet, film coated | ANDAANDA077797 | 2 | 0 |
| Upsher-Smith Laboratories, Inc. | capsule, extended release | ANDAANDA091281 | 2 | 0 |
| Cardinal Health 418, Inc.United States | tablet, film coated | ANDAANDA078643 | 1 | 34 |
| Aurobindo Pharma LimitedIndia | tablet, film coated | ANDAANDA078643 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA078048 | 1 | 5 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA077797 | 1 | 1 |
| MedSource LabsUnited States | tablet, film coated | ANDAANDA078643 | 1 | 1 |
| Unit Dose Solutions, Inc.United States | tablet, film coated | ANDAANDA208170 | 1 | 1 |
| AvKARE | tablet, film coated | ANDAANDA077563 | 1 | 0 |
| AvPAK | tablet, film coated | ANDAANDA090478 | 1 | 0 |
| NuCare Pharmaceutuicals,Inc. | tablet, film coated | ANDAANDA208170 | 1 | 0 |
| Quality Care Products, LLC | tablet, film coated | ANDAANDA078722 | 1 | 0 |
| SA3, LLC | tablet, film coated | ANDAANDA078722 | 1 | 0 |
| SOLA Pharmaceuticals, LLC | tablet, film coated | ANDAANDA077563 | 1 | 0 |
| Tonix Medicines, Inc. | tablet, orally disintegrating | NDANDA219428 | 1 | 0 |
Bulk ingredient listings
- ASCLEMED USA INC. DBA ENOVACHEMUnited States · 3 NDC
- ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States · 2 NDC
- Dipharma Francis SrlItaly · 2 NDC
- HAWAII REPACK INCUnited States · 2 NDC
- Derivados Quimicos SAUSpain · 1 NDC
- FLOWCHEM PHARMA PRIVATE LIMITEDIndia · 1 NDC
- Galenova IncCanada · 1 NDC
- HARMAN FINOCHEM LIMITEDIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Medichem SASpain · 1 NDC
- R.L.Fine Chem Private LimitedIndia · 1 NDC
- Vasudha Pharma Chem LimitedIndia · 1 NDC
- Village Pharma, LLC · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
Orange Book patents
4 unexpired patents list cyclobenzaprine hydrochloride as the active ingredient, expiring between Mar 2034 and Mar 2034. Application holder: TONIX PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes cyclobenzaprine hydrochloride?
- 52 companies list cyclobenzaprine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, ASCLEMED USA INC. DBA ENOVACHEM, NuCare Pharmaceuticals,Inc., RemedyRepack, Inc, International Medication Systems, Ltd.. 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 AMRIX?
- 50 companies list cyclobenzaprine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies cyclobenzaprine hydrochloride active ingredient?
- 17 companies list cyclobenzaprine hydrochloride as a bulk ingredient, including ASCLEMED USA INC. DBA ENOVACHEM, ADVANCED RX PHARMACY OF TENNESSEE LLC, Dipharma Francis Srl, HAWAII REPACK INC.