Data / Drug companies / Palonosetron hydrochloride
Palonosetron hydrochloride: 11 companies and 13 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Palonosetron hydrochloride is listed in the FDA National Drug Code Directory by 11 companies, with 13 products in commercial distribution. 12 of the products (92.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection; injection, solution, and the newest product started marketing on July 15, 2026.
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- Companies listing it
- 11
- Products
- 13
- Generic (ANDA) products
- 12 (92.3%)
- Application numbers
- 9
- Routes
- Intravenous
- Brand names
- Palonosetron
- openFDA record search
- api.fda.gov
Companies that list palonosetron hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Apotex Corp. | 2 | injection | Generic drugs (ANDA) | October 24, 2025 |
| Qilu Pharmaceutical Co., Ltd. | 2 | injection | Generic drugs (ANDA) | September 19, 2018 |
| Baxter Healthcare Corporation | 1 | injection | Generic drugs (ANDA) | November 12, 2021 |
| BluePoint Laboratories | 1 | injection | Generic drugs (ANDA) | July 15, 2026 |
| Cipla USA Inc. | 1 | injection | Authorized generics (NDA) | March 23, 2018 |
| Eugia US LLC | 1 | injection, solution | Generic drugs (ANDA) | November 6, 2018 |
| Meitheal Pharmaceuticals Inc. | 1 | injection, solution | Generic drugs (ANDA) | August 14, 2023 |
| Mylan Institutional LLC | 1 | injection, solution | Generic drugs (ANDA) | September 20, 2018 |
| Sagent Pharmaceuticals | 1 | injection, solution | Generic drugs (ANDA) | June 15, 2018 |
| Sandoz Inc | 1 | injection, solution | Generic drugs (ANDA) | March 23, 2018 |
| Teva Parenteral Medicines, Inc. | 1 | injection, solution | Generic drugs (ANDA) | March 23, 2018 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection | 7 | 53.8% |
| Injection, solution | 6 | 46.2% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 12 | 92.3% |
| Authorized generics (NDA) | 1 | 7.7% |
Pharmacologic classes
| Class | Products |
|---|---|
| Serotonin-3 Receptor Antagonist | 13 |
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.