Riluzole 50 mg tablet 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 at 20º to 25ºC (68º to 77ºF). Protect from bright light.
Key facts
- Active ingredient (INN)
- Riluzole
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 1000 tablets, 10 blister pack and 10 more
- Manufacturers
- Ascend LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaGlenmark PharmaceuticalsIndiaAvKAREFlorida Pharmaceutical Products
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF). Protect from bright light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07XX02 Riluzole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 June 2013
- Identifiers
- RxCUI 199206DailyMed set ID b117b981-476c-f9b8-e053-2995a90aee5f, f1ce57e8-d3fe-422c-8724-3101c258898a, 4c851be4-f0d0-4b24-baf9-427ddfc6f7b0 +2NDC 42291-775, 68462-381, 62756-538 +2Application ANDA206045, ANDA091394, ANDA091417 +1
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 |
|---|---|---|---|
| 500 tablet in 1 bottle | 67877-286-05 | Ascend LaboratoriesIndia | 31 March 2016 |
| 1000 tablet in 1 bottle | 67877-286-10 | Ascend LaboratoriesIndia | 31 March 2016 |
| 10 blister pack in 1 carton / 14 tablet in 1 blister pack | 67877-286-14 | Ascend LaboratoriesIndia | 31 March 2016 |
| 60 tablet in 1 bottle | 67877-286-60 | Ascend LaboratoriesIndia | 31 March 2016 |
| 90 tablet in 1 bottle | 67877-286-90 | Ascend LaboratoriesIndia | 31 March 2016 |
| 1000 tablet, film coated in 1 bottle | 68462-381-10 | Glenmark PharmaceuticalsIndia | 18 June 2013 |
| 60 tablet, film coated in 1 bottle | 68462-381-60 | Glenmark PharmaceuticalsIndia | 18 June 2013 |
| 1000 tablet, film coated in 1 bottle | 62756-538-18 | Sun Pharmaceutical IndustriesIndia | 18 June 2013 |
| 30 tablet, film coated in 1 bottle | 62756-538-83 | Sun Pharmaceutical IndustriesIndia | 18 June 2013 |
| 60 tablet, film coated in 1 bottle | 62756-538-86 | Sun Pharmaceutical IndustriesIndia | 18 June 2013 |
| 100 tablet, film coated in 1 bottle | 62756-538-88 | Sun Pharmaceutical IndustriesIndia | 18 June 2013 |
| 60 tablet, film coated in 1 bottle | 69076-200-60 | Florida Pharmaceutical Products | 1 January 2020 |
| 60 tablet, film coated in 1 bottle | 42291-775-60 | AvKARE | 7 October 2020 |
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 Riluzole
Clinical summary
Riluzole is a benzothiazole indicated for the treatment of amyotrophic lateral sclerosis (ALS). It is available as tablets, oral liquid and oral suspension. MedsAcross supplies Riluzole 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 RiluzoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TIGLUTIK prescribing information (Edw Pharma) · U.S. National Library of Medicine, DailyMed
- Rilutek: European public assessment report (EPAR) · European Medicines Agency
- Riluzole Zentiva: European public assessment report (EPAR) · European Medicines Agency
Need Riluzole 50 mg tablet 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.