Medicine
Dantrolene 50 mg capsule
Dantrolene 50 mg capsule is a generic prescription medicine for oral use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store between 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Dantrolene
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 1000 capsules and 5 more
- Manufacturers
- Amneal Pharmaceuticals of New YorkBryant Ranch PrepackElite LaboratoriesPar HealthRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store between 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M03CA01 Dantrolene
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 March 2005
- Identifiers
- RxCUI 856652, 856656, 856660DailyMed set ID e637fb20-6a17-4522-810a-990bf1409732, 11689f56-15e0-4350-b53f-ae96e5994fea, c3c45b27-f786-456e-95d6-2e38ef36190a +3NDC 64850-841, 49884-363, 0115-4422 +3Application ANDA076686, NDA017443, ANDA076856
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 0115-4422-01 | Amneal Pharmaceuticals of New York | 1 March 2005 |
| 500 capsule in 1 bottle | 0115-4422-02 | Amneal Pharmaceuticals of New York | 1 March 2005 |
| 1000 capsule in 1 bottle | 0115-4422-03 | Amneal Pharmaceuticals of New York | 1 March 2005 |
| 100 capsule in 1 bottle | 64850-841-01 | Elite Laboratories | 26 October 2005 |
| 100 capsule in 1 bottle | 49884-363-01 | Par Health | 28 March 2016 |
| 100 capsule in 1 bottle | 63629-2169-1 | Bryant Ranch Prepack | 11 March 2021 |
| 100 capsule in 1 bottle | 72162-2046-1 | Bryant Ranch Prepack | 14 June 2023 |
| 50 pouch in 1 box / 1 capsule in 1 pouch | 70518-4668-0 | Remedyrepack | 27 May 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Dantrolene
Clinical summary
Dantrolene is a skeletal muscle relaxant indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis), among other approved uses. MedsAcross supplies Dantrolene for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DantroleneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Dantrium prescribing information (Par Health) · U.S. National Library of Medicine, DailyMed
- Agilus: European public assessment report (EPAR) · European Medicines Agency
Need Dantrolene 50 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.