Medicine
Nucynta ER 100 mg extended-release tablet
Nucynta ER 100 mg extended-release tablet is a prescription medicine containing Tapentadol for oral use, marketed by Collegium Pharmaceutical, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C - 25°C (68°F - 77°F), excursions permitted to 15° C - 30°C (59°…
Key facts
- Active ingredient (INN)
- Tapentadol
- Brand
- Nucynta ER
- Strength
- 100 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 10 blister pack, 60 tablets
- Marketing authorisation holder
- Collegium Pharmaceutical
- Manufacturer
- Collegium Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store at 20°C - 25°C (68°F - 77°F), excursions permitted to 15° C - 30°C (59° F - 86°F). Protect from moisture. Store NUCYNTA ER securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N02AX06 Tapentadol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 April 2019
- Identifiers
- RxCUI 1148797, 1148800, 1148803 +7DailyMed set ID c3d04d70-0155-4147-9ce4-a3b1fad4b373NDC 24510-116Application NDA200533
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack | 24510-116-01 | Collegium Pharmaceutical | 19 April 2019 |
| 60 tablet, film coated, extended release in 1 bottle | 24510-116-60 | Collegium Pharmaceutical | 19 April 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 20 November 2008 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Tapentadol 100 mg extended-release tablet.
Other strengths and forms of Tapentadol
Clinical summary
Tapentadol is an opioid agonist indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults, among other approved uses. MedsAcross supplies Tapentadol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about TapentadolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TAPENTADOL prescribing information (Hikma Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Nucynta ER 100 mg extended-release tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.