Data / Drug companies / Dantrolene sodium
Dantrolene sodium: 14 companies and 26 products in the FDA NDC directory
Dantrolene sodium is listed in the FDA National Drug Code Directory by 14 companies, with 26 products in commercial distribution. 15 of the products (57.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; injection, powder, lyophilized, for solution; injection, and the newest product started marketing on May 27, 2026.
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- Companies listing it
- 14
- Products
- 26
- Generic (ANDA) products
- 15 (57.7%)
- Application numbers
- 6
- Routes
- Oral, Intravenous
- Brand names
- Dantrium, Revonto
- openFDA record search
- api.fda.gov
Companies that list dantrolene sodium
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 4 | capsule | Generic drugs (ANDA) | March 28, 2016 |
| Amneal Pharmaceuticals of New York LLC | 3 | capsule | Generic drugs (ANDA) | March 1, 2005 |
| Elite Laboratories, Inc. | 3 | capsule | Generic drugs (ANDA) | October 26, 2005 |
| Par Health USA, LLC | 3 | capsule | Authorized generics (NDA) | March 28, 2016 |
| Bryant Ranch Prepack | 2 | capsule | Authorized generics (NDA) | March 28, 2016 |
| Par Health USA, LLC | 2 | injection; capsule | New drug applications (NDA) | April 20, 2009 |
| Remedyrepack Inc. | 2 | capsule | Authorized generics (NDA) | May 27, 2026 |
| American Health Packaging | 1 | capsule | Generic drugs (ANDA) | September 29, 2008 |
| AvPAK | 1 | capsule | Generic drugs (ANDA) | March 9, 2021 |
| Cardinal Health 107, LLC | 1 | capsule | Generic drugs (ANDA) | September 25, 2008 |
| Eagle Pharmaceuticals, Inc. | 1 | injection, suspension | New drug applications (NDA) | July 23, 2014 |
| Major Pharmaceuticals | 1 | capsule | Generic drugs (ANDA) | March 1, 2005 |
| ProPharma Distribution | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | April 9, 2021 |
| Uswm, LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | April 9, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 22 | 84.6% |
| Injection, powder, lyophilized, for solution | 2 | 7.7% |
| Injection | 1 | 3.8% |
| Injection, suspension | 1 | 3.8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 15 | 57.7% |
| Authorized generics (NDA) | 8 | 30.8% |
| New drug applications (NDA) | 3 | 11.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Skeletal Muscle Relaxant | 26 |
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.