Active ingredient
Alosetron
16 finished FDA listings contain Alosetron as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ALOSETRON HYDROCHLORIDE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 8
- Strengths listed
- .5 mg/1 · 1 mg/1
- Brand names in FDA listings
- Lotronex
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 85248
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021107 | LEGACY | 2000-02-09 | 4 |
| ANDA 206647 | AMNEAL PHARMS | 2016-12-22 | 6 |
| ANDA 211621 | ADAPTIS | 2019-09-16 | 2 |
| ANDA 213614 | MANKIND PHARMA | 2020-09-09 | 4 |
Official labeling on DailyMed
- LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [SEBELA PHARMACEUTICALS INC.] · version 8 · 2026-07-02
- ALOSETRON TABLET [BRYANT RANCH PREPACK] · version 102 · 2026-04-03
- ALOSETRON TABLET [BRYANT RANCH PREPACK] · version 103 · 2026-04-03
- LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [LEGACY PHARMA USA INC.] · version 2 · 2026-03-24
- ALOSETRON HYDROCHLORIDE TABLET [EYWA PHARMA INC] · version 3 · 2025-11-17
- ALOSETRON TABLET [LIFESTAR PHARMA LLC] · version 5 · 2025-10-06
- ALOSETRON HYDROCHLORIDE TABLET, FILM COATED [AVKARE] · version 3 · 2025-09-11
- ALOSETRON HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] · version 18 · 2024-10-25
- ALOSETRON HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 1 · 2023-10-27
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.