Active ingredient
Tapentadol
26 finished FDA listings contain Tapentadol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TAPENTADOL HYDROCHLORIDE
- Dosage forms
- Solution, Tablet, Film Coated, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 100 mg/1 · 150 mg/1 · 20 mg/ml · 200 mg/1 · 250 mg/1 · 50 mg/1 · 75 mg/1
- Brand names in FDA listings
- Nucynta, Nucynta Er, Tapentadol
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 787390
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022304 | COLLEGIUM PHARM INC | 2008-11-20 | 6 |
| NDA 200533 | COLLEGIUM PHARM INC | 2011-08-25 | 10 |
| ANDA 219119 | NOVITIUM PHARMA | 2026-01-26 | 1 |
| ANDA 214378 | EPIC PHARMA LLC | 2026-01-27 | 3 |
| ANDA 220865 | MSN | 2026-09-03 | 6 |
Official labeling on DailyMed
- TAPENTADOL HYDROCHLORIDE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2026-09-07
- TAPENTADOL HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] · version 2 · 2026-07-28
- TAPENTADOL (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC.] · version 2 · 2026-03-05
- TAPENTADOL (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [HIKMA PHARMACEUTICALS USA INC.] · version 3 · 2026-03-04
- TAPENTADOL HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA LLC] · version 9 · 2026-01-30
- NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [COLLEGIUM PHARMACEUTICAL, INC.] · version 8 · 2026-01-06
- NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [COLLEGIUM PHARMACEUTICAL, INC.] · version 7 · 2026-01-06
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.