Data / Drug companies / Tapentadol hydrochloride
Tapentadol hydrochloride: 6 companies and 26 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Tapentadol hydrochloride is listed in the FDA National Drug Code Directory by 6 companies, with 26 products in commercial distribution. 10 of the products (38.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, film coated, extended release; solution, and the newest product started marketing on September 14, 2026.
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- Companies listing it
- 6
- Products
- 26
- Generic (ANDA) products
- 10 (38.5%)
- Application numbers
- 5
- Controlled substance schedule
- Schedule II
- Routes
- Oral
- Brand names
- Tapentadol, Nucynta Er, Nucynta
- openFDA record search
- api.fda.gov
Companies that list tapentadol hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Collegium Pharmaceutical, Inc. | 8 | tablet, film coated, extended release; tablet, film coated | New drug applications (NDA) | April 19, 2019 |
| Hikma Pharmaceuticals USA Inc. | 8 | tablet, film coated, extended release; tablet, film coated | Authorized generics (NDA) | December 15, 2025 |
| AvKARE | 3 | tablet, film coated | Generic drugs (ANDA) | September 14, 2026 |
| Epic Pharma, LLC | 3 | tablet, film coated | Generic drugs (ANDA) | December 31, 2021 |
| Novadoz Pharmaceuticals LLC | 3 | tablet, film coated | Generic drugs (ANDA) | September 3, 2026 |
| Ani Pharmaceuticals, Inc. | 1 | solution | Generic drugs (ANDA) | July 13, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 15 | 57.7% |
| Tablet, film coated, extended release | 10 | 38.5% |
| Solution | 1 | 3.8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 10 | 38.5% |
| New drug applications (NDA) | 8 | 30.8% |
| Authorized generics (NDA) | 8 | 30.8% |
Pharmacologic classes
| Class | Products |
|---|---|
| Opioid Agonist | 26 |
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.