Drug
Who makes alosetron hydrochloride?
6 companies list alosetron hydrochloride as a human prescription drug, including under the names LOTRONEX. Forms: tablet; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing alosetron hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Amneal Pharmaceuticals of New York, LLCIndia | tablet, film coated | ANDAANDA206647 | 2 | 14 |
| Amneal Ireland LimitedIreland | tablet, film coated | ANDAANDA206647 | 2 | 1 |
| Legacy Pharma USA Inc.United States | tablet | NDANDA021107 | 2 | 1 |
| AvKARE | tablet, film coated | ANDAANDA206647 | 2 | 0 |
| Eywa Pharma Inc | tablet | ANDAANDA211621 | 2 | 0 |
| Sebela Pharmaceuticals Inc. | tablet | NDANDA021107 | 2 | 0 |
Bulk ingredient listings
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes alosetron hydrochloride?
- 6 companies list alosetron hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Amneal Pharmaceuticals of New York, LLC, Amneal Ireland Limited, Legacy Pharma USA Inc., AvKARE, Eywa Pharma Inc. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic LOTRONEX?
- 4 companies list alosetron hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies alosetron hydrochloride active ingredient?
- 2 companies list alosetron hydrochloride as a bulk ingredient, including NURAY CHEMICALS PRIVATE LIMITED, Sionc Pharmaceuticals Private Limited.