Medicine
Tramadol 50 mg tablet
Tramadol 50 mg tablet is a generic prescription medicine for oral use, made by 31 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 20° to 25°C (68° to 77°F). Store tramadol hydrochloride tablets…
Key facts
- Active ingredient (INN)
- Tramadol
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 306 more
- Manufacturers
- Aurobindo PharmaIndiaStrides PharmaIndiaUnichem LaboratoriesIndiaAmneal Pharmaceuticals NYRising Pharma HoldingsAmneal PharmaceuticalsAdvagen PharmaCranbury PharmaceuticalsTruPharmaBryant Ranch Prepack31 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store tramadol hydrochloride tablets securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N02AX02 Tramadol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 June 2002
- Identifiers
- RxCUI 835603, 2179635, 2670390 +1DailyMed set ID 2236031d-8596-4c21-8b16-83aa3e4122c1, d7e75fd3-18d1-4370-bb63-c9dd8a2c1719, 552955e6-2bb3-8755-e063-6394a90ab21c +37NDC 82804-114, 82804-142, 82868-110 +37Application ANDA202075, ANDA208708, ANDA211825 +5
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
A sample of 40 packs from 31 labelers. The register lists 309 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 59651-441-01 | Aurobindo PharmaIndia | 23 September 2020 |
| 500 tablet, film coated in 1 bottle | 59651-441-05 | Aurobindo PharmaIndia | 23 September 2020 |
| 1000 tablet, film coated in 1 bottle | 59651-441-99 | Aurobindo PharmaIndia | 23 September 2020 |
| 100 tablet in 1 bottle | 64380-791-01 | Strides PharmaIndia | 27 July 2026 |
| 500 tablet in 1 bottle | 64380-791-02 | Strides PharmaIndia | 27 July 2026 |
| 1000 tablet in 1 bottle | 64380-791-03 | Strides PharmaIndia | 27 July 2026 |
| 100 tablet, film coated in 1 bottle, plastic | 29300-355-01 | Unichem LaboratoriesIndia | 4 November 2019 |
| 500 tablet, film coated in 1 bottle, plastic | 29300-355-05 | Unichem LaboratoriesIndia | 4 November 2019 |
| 1000 tablet, film coated in 1 bottle, plastic | 29300-355-10 | Unichem LaboratoriesIndia | 4 November 2019 |
| 100 tablet, coated in 1 bottle | 60219-2348-1 | Amneal Pharmaceuticals NY | 13 February 2023 |
| 10 tablet, coated in 1 bottle | 60219-2348-4 | Amneal Pharmaceuticals NY | 13 February 2023 |
| 500 tablet, coated in 1 bottle | 60219-2348-5 | Amneal Pharmaceuticals NY | 13 February 2023 |
| 1000 tablet, coated in 1 bottle | 60219-2348-7 | Amneal Pharmaceuticals NY | 13 February 2023 |
| 100 tablet, coated in 1 bottle | 69238-2348-1 | Amneal Pharmaceuticals NY | 15 November 2010 |
| 10 tablet, coated in 1 bottle | 69238-2348-4 | Amneal Pharmaceuticals NY | 15 November 2010 |
| 500 tablet, coated in 1 bottle | 69238-2348-5 | Amneal Pharmaceuticals NY | 15 November 2010 |
| 1000 tablet, coated in 1 bottle | 69238-2348-7 | Amneal Pharmaceuticals NY | 15 November 2010 |
| 100 tablet, film coated in 1 bottle | 16571-716-01 | Rising Pharma Holdings | 23 September 2020 |
| 1000 tablet, film coated in 1 bottle | 16571-716-10 | Rising Pharma Holdings | 23 September 2020 |
| 500 tablet, film coated in 1 bottle | 16571-716-50 | Rising Pharma Holdings | 23 September 2020 |
| 100 tablet in 1 bottle | 64980-614-01 | Rising Pharma Holdings | 5 August 2024 |
| 1000 tablet in 1 bottle | 64980-614-10 | Rising Pharma Holdings | 5 August 2024 |
| 500 tablet in 1 bottle | 64980-614-50 | Rising Pharma Holdings | 5 August 2024 |
| 1000 tablet, coated in 1 bottle | 72888-080-00 | Advagen Pharma | 24 July 2023 |
| 100 tablet, coated in 1 bottle | 72888-080-01 | Advagen Pharma | 24 July 2023 |
| 500 tablet, coated in 1 bottle | 72888-080-05 | Advagen Pharma | 24 July 2023 |
| 10 tablet, coated in 1 bottle | 65162-627-01 | Amneal Pharmaceuticals | 15 November 2010 |
| 100 tablet, coated in 1 bottle | 65162-627-10 | Amneal Pharmaceuticals | 15 November 2010 |
| 1000 tablet, coated in 1 bottle | 65162-627-11 | Amneal Pharmaceuticals | 15 November 2010 |
| 500 tablet, coated in 1 bottle | 65162-627-50 | Amneal Pharmaceuticals | 15 November 2010 |
| 100 tablet, film coated in 1 bottle | 27808-301-01 | Cranbury Pharmaceuticals | 22 December 2024 |
| 500 tablet, film coated in 1 bottle | 27808-301-02 | Cranbury Pharmaceuticals | 22 December 2024 |
| 1000 tablet, film coated in 1 bottle | 27808-301-03 | Cranbury Pharmaceuticals | 22 December 2024 |
| 100 tablet, film coated in 1 bottle | 0093-3301-01 | Teva Pharmaceuticals | 17 September 2024 |
| 500 tablet, film coated in 1 bottle | 0093-3301-05 | Teva Pharmaceuticals | 12 September 2024 |
| 1000 tablet, coated in 1 bottle | 52817-195-00 | Trupharma | 1 September 2020 |
| 100 tablet, coated in 1 bottle | 52817-195-10 | Trupharma | 1 September 2020 |
| 500 tablet, coated in 1 bottle | 52817-195-50 | Trupharma | 1 September 2020 |
| 50 tablet in 1 bottle | 71335-2518-0 | Bryant Ranch Prepack | 4 November 2024 |
| 30 tablet in 1 bottle | 71335-2518-1 | Bryant Ranch Prepack | 4 November 2024 |
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 3 March 1995 | 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
Other strengths and forms of Tramadol
Clinical summary
Tramadol is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, among other approved uses. MedsAcross supplies Tramadol 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 TramadolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tramadol Hydrochloride Extended-Release prescribing information (Trigen Laboratories) · U.S. National Library of Medicine, DailyMed
Need Tramadol 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.