Medicine
Lotronex 1 mg tablet
Lotronex 1 mg tablet is a prescription medicine containing Alosetron for oral use, marketed by Legacy Pharma, 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 20-25°C (68-77°F) (USP Controlled Room Temperature). Protect from…
Key facts
- Active ingredient (INN)
- Alosetron
- Brand
- Lotronex
- Strength
- 1 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- Legacy Pharma
- Manufacturers
- Legacy PharmaSebela Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20-25°C (68-77°F) (USP Controlled Room Temperature). 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
- 11 July 2016
- Identifiers
- RxCUI 259306, 261362, 403975 +1DailyMed set ID 35cbb9d5-639b-207a-e054-00144ff88e88, c216e967-436f-475a-8e6a-2ad11adc63afNDC 54766-895, 83107-012Application NDA021107
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle | 83107-012-30 | Legacy Pharma | 1 January 2026 |
| 30 tablet in 1 bottle | 54766-895-03 | Sebela Pharmaceuticals | 11 July 2016 |
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 1 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 Lotronex 1 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.