Quick answers
- What is Tapentadol hydrochloride used for?
- The FDA-approved label (Nucynta, Collegium Pharmaceutical, Inc., December 30, 2025) says: “NUCYNTA (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tapentadol hydrochloride have a boxed warning?
- Yes. The FDA label for Nucynta has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NUCYNTA TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NUCYNTA TABLETS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tapentadol hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tapentadol hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tapentadol hydrochloride?
- 6 companies list prescription products of Tapentadol hydrochloride in the FDA NDC Directory, including Collegium Pharmaceutical, Inc., Hikma Pharmaceuticals USA Inc. and Epic Pharma, LLC.
What Tapentadol hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NUCYNTA (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. …
— FDA label: Nucynta, Collegium Pharmaceutical, Inc., effective December 30, 2025. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NUCYNTA TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NUCYNTA TABLETS
. Read it on the full label →
7 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, film coated, extended release · Solution |
|---|---|
| Route | Oral |
| Prescription products | 26 in the FDA NDC Directory |
| Brand names | Nucynta ER, Nucynta |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tapentadol hydrochloride 100 mg tablet, film coated | Generic | $14.43 per tablet |
| tapentadol hydrochloride 100 mg tablet, film coated, extended release | Generic | $21.34 per tablet |
| tapentadol hydrochloride 200 mg tablet, film coated, extended release | Generic | $35.01 per tablet |
| tapentadol hydrochloride 50 mg tablet, film coated | Generic | $8.51 per tablet |
| tapentadol hydrochloride 50 mg tablet, film coated, extended release | Generic | $12.15 per tablet |
| tapentadol hydrochloride 75 mg tablet, film coated | Generic | $10.16 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Collegium Pharmaceutical, Inc.8 products
- Hikma Pharmaceuticals USA Inc.8 products
- Epic Pharma, LLC3 products
- Novadoz Pharmaceuticals LLC3 products
- AvKARE3 products
- ANI Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022304 NUCYNTA | Collegium Pharm Inc | November 20, 2008 | 22, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA200533 NUCYNTA ER | Collegium Pharm Inc | August 25, 2011 | 20, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
Generic approvals (3)
- ANDA219119Novitium Pharma · January 26, 2026
- ANDA214378Epic Pharma LLC · January 27, 2026
- ANDA220865Msn · September 3, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nucynta, Collegium Pharmaceutical, Inc., effective December 30, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →