Data / Drug companies / Tolvaptan
Tolvaptan: 9 companies and 51 products in the FDA NDC directory
Tolvaptan is listed in the FDA National Drug Code Directory by 9 companies, with 51 products in commercial distribution. 42 of the products (82.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; kit, and the newest product started marketing on September 1, 2026.
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- Companies listing it
- 9
- Products
- 51
- Generic (ANDA) products
- 42 (82.4%)
- Application numbers
- 11
- Routes
- Oral
- Brand names
- Jynarque, Jynarque, Samsca
- openFDA record search
- api.fda.gov
Companies that list tolvaptan
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Ascend Laboratories, LLC | 13 | tablet; kit | Generic drugs (ANDA) | September 1, 2026 |
| Apotex Corp. | 9 | kit; tablet | Generic drugs (ANDA) | August 6, 2026 |
| Otsuka America Pharmaceutical, Inc. | 9 | kit; tablet | New drug applications (NDA) | January 13, 2020 |
| Lupin Pharmaceuticals, Inc. | 7 | kit; tablet | Generic drugs (ANDA) | May 12, 2025 |
| Teva Pharmaceuticals, Inc. | 5 | kit | Generic drugs (ANDA) | August 27, 2026 |
| Camber Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | September 6, 2022 |
| NorthStar RxLLC | 2 | tablet | Generic drugs (ANDA) | June 21, 2023 |
| Novadoz Pharmaceuticals LLC | 2 | tablet | Generic drugs (ANDA) | June 21, 2023 |
| Par Health USA, LLC | 2 | tablet | Generic drugs (ANDA) | March 10, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 26 | 51% |
| Kit | 25 | 49% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 42 | 82.4% |
| New drug applications (NDA) | 9 | 17.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Vasopressin V2 Receptor Antagonist | 26 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). 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.