Medicine
Tapentadol 50 mg tablet
Tapentadol 50 mg tablet is a generic prescription medicine for oral use, made by 4 labelers, 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 20ºC to 25°C (68°F to 77ºF), excursions permitted to 15ºC to 30ºC…
Key facts
- Active ingredient (INN)
- Tapentadol
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets and 1 more
- Manufacturers
- Novadoz PharmaceuticalsIndiaAvKAREEpic PharmaHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20ºC to 25°C (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Protect from moisture. Store tapentadol tablets securely and dispose of properly. imprint.jpg imprint.jpg imprint.jpg
- 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
- 31 December 2021
- Identifiers
- RxCUI 825409, 825411, 825413DailyMed set ID fecd2104-5bf3-47ed-a6f0-5c6ebb0a17b4, 5b769a76-5ca5-b2e9-e063-6394a90a1b1b, d4c5938a-68f0-46d2-9bad-8988d5724b09 +1NDC 42806-626, 73190-081, 72205-369 +1Application ANDA214378, ANDA220865, NDA022304
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 72205-369-91 | Novadoz PharmaceuticalsIndia | 3 September 2026 |
| 100 tablet, film coated in 1 bottle | 42806-626-01 | Epic Pharma | 31 December 2021 |
| 100 tablet, film coated in 1 bottle, plastic | 0054-0942-25 | Hikma Pharmaceuticals | 15 December 2025 |
| 100 tablet, film coated in 1 bottle | 73190-081-01 | AvKARE | 14 September 2026 |
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 50 mg 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 Tapentadol 50 mg 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.