Data / Drug companies / Alosetron hydrochloride
Alosetron hydrochloride: 6 companies and 12 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Alosetron hydrochloride is listed in the FDA National Drug Code Directory by 6 companies, with 12 products in commercial distribution. 8 of the products (66.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, and the newest product started marketing on January 1, 2026.
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- Companies listing it
- 6
- Products
- 12
- Generic (ANDA) products
- 8 (66.7%)
- Application numbers
- 3
- Routes
- Oral
- Brand names
- Lotronex
- openFDA record search
- api.fda.gov
Companies that list alosetron hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Amneal Pharmaceuticals LLC | 2 | tablet, film coated | Generic drugs (ANDA) | January 2, 2017 |
| Amneal Pharmaceuticals of New York LLC | 2 | tablet, film coated | Generic drugs (ANDA) | September 6, 2023 |
| AvKARE | 2 | tablet, film coated | Generic drugs (ANDA) | July 25, 2025 |
| Eywa Pharma Inc | 2 | tablet | Generic drugs (ANDA) | February 1, 2019 |
| Legacy Pharma USA Inc. | 2 | tablet | New drug applications (NDA) | January 1, 2026 |
| Sebela Pharmaceuticals Inc. | 2 | tablet | New drug applications (NDA) | July 11, 2016 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 6 | 50% |
| Tablet | 6 | 50% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 8 | 66.7% |
| New drug applications (NDA) | 4 | 33.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Serotonin-3 Receptor Antagonist | 12 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.