Drug
Who makes dantrolene sodium?
12 companies list dantrolene sodium as a human prescription drug, including under the names Dantrium, Revonto. Forms: capsule; injection; injection, powder, lyophilized, for solution; injection, suspension. Routes: intravenous, 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 dantrolene sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule | ANDA, NDA AUTHORIZED GENERICANDA076686, NDA017443 | 6 | 1 |
| Par Health USA, LLCIndia | capsule; injection | NDA, NDA AUTHORIZED GENERICNDA017443, NDA018264 | 5 | 5 |
| Amneal Pharmaceuticals of New York, LLCIndia | capsule | ANDAANDA076856 | 3 | 14 |
| Elite Laboratories, Inc.United States | capsule | ANDAANDA076686 | 3 | 1 |
| RemedyRepack, IncUnited States | capsule | NDA AUTHORIZED GENERICNDA017443 | 2 | 1 |
| Cardinal Health 418, Inc.United States | capsule | ANDAANDA076856 | 1 | 34 |
| Eagle Pharmaceuticals, Inc.United States | injection, suspension | NDANDA205579 | 1 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | ANDAANDA076856 | 1 | 5 |
| ProPharma Distribution, LLC.United States | injection, powder, lyophilized, for solution | ANDAANDA078378 | 1 | 3 |
| AvPAK | capsule | ANDAANDA076856 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule | ANDAANDA076856 | 1 | 0 |
| USWM, LLC | injection, powder, lyophilized, for solution | ANDAANDA078378 | 1 | 0 |
Bulk ingredient listings
- AZICO BIOPHORE INDIA PRIVATE LIMITEDIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- HAS Healthcare Advanced Synthesis SASwitzerland · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Enquiry
Common questions
- Who makes dantrolene sodium?
- 12 companies list dantrolene sodium as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Par Health USA, LLC, Amneal Pharmaceuticals of New York, LLC, Elite Laboratories, Inc., RemedyRepack, Inc. 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 Dantrium?
- 9 companies list dantrolene sodium 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 dantrolene sodium active ingredient?
- 5 companies list dantrolene sodium as a bulk ingredient, including AZICO BIOPHORE INDIA PRIVATE LIMITED, Darmerica, LLC, HAS Healthcare Advanced Synthesis SA, ScinoPharm Taiwan, Ltd..