Quick answers
- What is Nucynta ER?
- Nucynta ER is a brand name of Tapentadol hydrochloride, a prescription medicine. The FDA NDC Directory lists 5 Nucynta ER products in 5 strengths and forms.
- Who makes Nucynta ER?
- Collegium Pharm Inc holds the FDA application for Nucynta ER (NDA200533, approved August 25, 2011).
- Is there a generic or store brand of Nucynta ER?
- Yes. The FDA NDC Directory lists 5 other products with the same active ingredients, strength and form as a Nucynta ER product, 5 of them generic. Ask your pharmacist whether one is right for you.
- Has Nucynta ER been recalled?
- No recall linked to Nucynta ER products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Nucynta ER is
Each Nucynta ER 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, extended release (oral) | Nucynta ER | 1 product, 1 company | DailyMed |
| tapentadol hydrochloride 150 mg tablet, film coated, extended release (oral) | Nucynta ER | 1 product, 1 company | DailyMed |
| tapentadol hydrochloride 200 mg tablet, film coated, extended release (oral) | Nucynta ER | 1 product, 1 company | DailyMed |
| tapentadol hydrochloride 250 mg tablet, film coated, extended release (oral) | Nucynta ER | 1 product, 1 company | DailyMed |
| tapentadol hydrochloride 50 mg tablet, film coated, extended release (oral) | Nucynta ER | 1 product, 1 company | 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 |
|---|---|---|---|
| NDA200533 | Collegium Pharm Inc | August 25, 2011 | 5 |
Companies that list Nucynta ER
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Nucynta ER products.
- Collegium Pharmaceutical, Inc.5 products
Recalls
No recall linked to Nucynta ER 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.