Drug
Who makes tapentadol hydrochloride?
6 companies list tapentadol hydrochloride as a human prescription drug, including under the names Nucynta, Nucynta ER. Forms: solution; tablet, film coated; tablet, film coated, extended release. 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 tapentadol hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | tablet, film coated; tablet, film coated, extended release | NDA AUTHORIZED GENERICNDA022304, NDA200533 | 8 | 4 |
| Collegium Pharmaceutical, Inc. | tablet, film coated; tablet, film coated, extended release | NDANDA022304, NDA200533 | 8 | 0 |
| Epic Laboratories, LLCUnited States | tablet, film coated | ANDAANDA214378 | 3 | 3 |
| AvKARE | tablet, film coated | ANDAANDA220865 | 3 | 0 |
| Novadoz Pharmaceuticals LLC | tablet, film coated | ANDAANDA220865 | 3 | 0 |
| ANI Pharmaceuticals, Inc.United States | solution | ANDAANDA219119 | 1 | 1 |
Bulk ingredient listings
- Curia Missouri, Inc.United States · 1 NDC
- Janssen Pharmaceuticals Sciences Unlimited Company · 1 NDC
- Pisgah Laboratories IncUnited States · 1 NDC
- S&B Pharma LLC dba Norac PharmaUnited States · 1 NDC
- Siegfried USA, LLCUnited States · 1 NDC
Orange Book patents
4 unexpired patents list tapentadol hydrochloride as the active ingredient, expiring between Apr 2028 and Mar 2029. Application holder: COLLEGIUM PHARMACEUTICAL INC.
Enquiry
Common questions
- Who makes tapentadol hydrochloride?
- 6 companies list tapentadol hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., Collegium Pharmaceutical, Inc., Epic Laboratories, LLC, AvKARE, Novadoz Pharmaceuticals LLC. 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 Nucynta?
- 4 companies list tapentadol hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies tapentadol hydrochloride active ingredient?
- 5 companies list tapentadol hydrochloride as a bulk ingredient, including Curia Missouri, Inc., Janssen Pharmaceuticals Sciences Unlimited Company, Pisgah Laboratories Inc, S&B Pharma LLC dba Norac Pharma.