Quick answers
- What is Nucynta?
- Nucynta is a brand name of Tapentadol hydrochloride, a prescription medicine. The FDA NDC Directory lists 3 Nucynta products in 3 strengths and forms.
- Who makes Nucynta?
- Collegium Pharm Inc holds the FDA application for Nucynta (NDA022304, approved November 20, 2008).
- Is there a generic or store brand of Nucynta?
- Yes. The FDA NDC Directory lists 12 other products with the same active ingredients, strength and form as a Nucynta product, 12 of them generic. Ask your pharmacist whether one is right for you.
- Has Nucynta been recalled?
- No recall linked to Nucynta products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Nucynta is
Each Nucynta product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Tapentadol hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| tapentadol hydrochloride 100 mg tablet, film coated (oral) | Nucynta | 4 products, 4 companies | DailyMed |
| tapentadol hydrochloride 50 mg tablet, film coated (oral) | Nucynta | 4 products, 4 companies | DailyMed |
| tapentadol hydrochloride 75 mg tablet, film coated (oral) | Nucynta | 4 products, 4 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Tapentadol hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022304 | Collegium Pharm Inc | November 20, 2008 | 3 |
Companies that list Nucynta
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Nucynta products.
- Collegium Pharmaceutical, Inc.3 products
Recalls
No recall linked to Nucynta products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.