Medicine
Alosetron 0.5 mg tablet
Alosetron 0.5 mg tablet is a generic prescription medicine for oral use, made by 6 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 20° to 25°C (68° to 77°F). Protect from light and moisture.
Key facts
- Active ingredient (INN)
- Alosetron
- Brand
- Sold under the generic name
- Strength
- 0.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 500 tablets and 4 more
- Manufacturers
- Lifestar PharmaIndiaAmneal PharmaceuticalsAmneal Pharmaceuticals of New YorkAvKAREBryant Ranch PrepackEywa Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A03AE01 Alosetron
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 January 2017
- Identifiers
- RxCUI 259306, 403975DailyMed set ID 2927e7d0-b1b8-4944-a7e8-97b60eb9bb71, 2846a244-7540-442b-81bc-638e641497ce, d62b2c5a-1693-4e67-96d5-197e1fdc8694 +3NDC 53746-248, 70756-702, 71930-010 +3Application ANDA206647, ANDA213614, ANDA211621
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 |
|---|---|---|---|
| 30 tablet in 1 bottle | 70756-702-30 | Lifestar PharmaIndia | 14 September 2020 |
| 30 tablet, film coated in 1 bottle | 65162-248-03 | Amneal Pharmaceuticals | 2 January 2017 |
| 500 tablet, film coated in 1 bottle | 65162-248-50 | Amneal Pharmaceuticals | 2 January 2017 |
| 30 tablet, film coated in 1 bottle | 53746-248-30 | Amneal Pharmaceuticals of New York | 6 September 2023 |
| 30 tablet in 1 bottle | 71930-010-30 | Eywa Pharma | 1 February 2019 |
| 30 tablet, film coated in 1 bottle | 73190-035-30 | AvKARE | 25 July 2025 |
| 30 tablet in 1 bottle | 63629-2517-1 | Bryant Ranch Prepack | 29 April 2022 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 9 February 2000 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Alternatives
Other makers and brands of Alosetron 0.5 mg tablet.
Other strengths and forms of Alosetron
Clinical summary
Alosetron is a serotonin-3 receptor antagonist indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have. It is available as tablets for oral use. MedsAcross supplies Alosetron 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 AlosetronFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LOTRONEX prescribing information (Sebela Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Alosetron 0.5 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.