Drug
Who makes metaxalone?
32 companies list metaxalone as a human prescription drug. Forms: 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 metaxalone
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA203695, ANDA204770 | 6 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA203399, ANDA203695, ANDA204770 | 4 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDAANDA204770, ANDA207466 | 3 | 1 |
| Advanced Rx of Tennessee, LLC | tablet | ANDAANDA203399, ANDA207466 | 3 | 0 |
| Amneal Pharmaceuticals of New York, LLCIndia | tablet | ANDAANDA040486, ANDA203399 | 2 | 14 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA204770 | 2 | 3 |
| ScieGen Pharmaceuticals India Private LimitedIndia | tablet | ANDAANDA207466 | 2 | 3 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet | ANDAANDA203695, ANDA204770 | 2 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | ANDAANDA203695, ANDA204770 | 2 | 1 |
| Direct RxUnited States | tablet | ANDAANDA203695, ANDA204770 | 2 | 1 |
| Northwind Health Company, LLCUnited States | tablet | ANDAANDA204770, ANDA207466 | 2 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA207466 | 2 | 1 |
| PHOENIX RX LLCUnited States | tablet | ANDAANDA203695, ANDA204770 | 2 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA204770, ANDA207466 | 2 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet | ANDAANDA203695, ANDA204770 | 2 | 1 |
| Doc Rx | tablet | ANDAANDA203695, ANDA204770 | 2 | 0 |
| Sportpharm LLC | tablet | ANDAANDA203695, ANDA204770 | 2 | 0 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | tablet | ANDAANDA207466 | 1 | 7 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA207466 | 1 | 5 |
| Actavis LLCUnited States | tablet | ANDAANDA203695 | 1 | 1 |
| Amneal Ireland LimitedIreland | tablet | ANDAANDA203399 | 1 | 1 |
| Lannett Company, LLCUnited States | tablet | ANDAANDA204770 | 1 | 1 |
| Misemer PharmaceuticalUnited States | tablet | ANDAANDA207466 | 1 | 1 |
| AvKARE | tablet | ANDAANDA203399 | 1 | 0 |
| AvPAK | tablet | ANDAANDA203399 | 1 | 0 |
| Blue Heron Pharmaceuticals, LLC | tablet | ANDAANDA207466 | 1 | 0 |
| BluePoint Laboratories Inc. | tablet | ANDAANDA207466 | 1 | 0 |
| Dr. Reddys Laboratories Limited | tablet | ANDAANDA207466 | 1 | 0 |
| Highmark Pharma LLC | tablet | ANDAANDA207466 | 1 | 0 |
| INA Pharmaceutics, Inc. | tablet | NDANDA022503 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA207466 | 1 | 0 |
| Quality Care Products, LLC | tablet | ANDAANDA204770 | 1 | 0 |
Bulk ingredient listings
- ANGELINI PHARMA ITALIA AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. SPAItaly · 1 NDC
- Chunghwa Chemical Synthesis & Biotech Co., Ltd. · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Lee Pharma LimitedIndia · 1 NDC
- RAKS Pharma Pvt. LimitedIndia · 1 NDC
- Syn-Tech Chem. & Pharm. Co., Ltd.Taiwan · 1 NDC
- Zhejiang Apeloa Jiayuan Pharmaceutical Co LtdChina · 1 NDC
Orange Book patents
2 unexpired patents list metaxalone as the active ingredient, expiring between Jul 2039 and May 2043. Application holder: PRIMUS PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes metaxalone?
- 32 companies list metaxalone as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Proficient Rx LP, Preferred Pharmaceuticals Inc., Advanced Rx of Tennessee, LLC, Amneal Pharmaceuticals of New York, LLC. 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 metaxalone?
- 31 companies list metaxalone under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies metaxalone active ingredient?
- 8 companies list metaxalone as a bulk ingredient, including ANGELINI PHARMA ITALIA AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. SPA, Chunghwa Chemical Synthesis & Biotech Co., Ltd., Cohance Lifesciences Limited, Hetero Drugs Limited.