Medicine
Tramadol 300 mg extended-release tablet
Tramadol 300 mg extended-release tablet is a generic prescription medicine for oral use, made by 11 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store…
Key facts
- Active ingredient (INN)
- Tramadol
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 1000 tablets and 34 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaMacleods PharmaceuticalsIndiaLupinIndiaBryant Ranch PrepackProficient RxAsclemedAdvanced Rx Pharmacy of TennesseeDirect_RxMedsource PharmaceuticalsNuCare Pharmaceuticals,Inc
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store tramadol hydrochloride extended release 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
- 26 September 2011
- Identifiers
- RxCUI 833713, 833709, 833711 +3DailyMed set ID acd5d8e0-a4cc-4654-ae04-faff347a60ca, a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc, a07ed444-54e4-4d45-b6a1-6ea2f6dedc61 +13NDC 71335-9670, 76420-538, 33342-271 +13Application ANDA200503, ANDA209404, ANDA091607 +1
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 |
|---|---|---|---|
| 30 tablet, extended release in 1 bottle | 68180-699-06 | LupinIndia | 19 August 2014 |
| 100 tablet, extended release in 1 bottle | 47335-537-08 | Sun Pharmaceutical IndustriesIndia | 30 December 2011 |
| 1000 tablet, extended release in 1 bottle | 47335-537-18 | Sun Pharmaceutical IndustriesIndia | 30 December 2011 |
| 30 tablet, extended release in 1 bottle | 47335-537-83 | Sun Pharmaceutical IndustriesIndia | 30 December 2011 |
| 100 tablet, extended release in 1 bottle | 47335-537-88 | Sun Pharmaceutical IndustriesIndia | 30 December 2011 |
| 100 tablet, extended release in 1 bottle | 47335-861-08 | Sun Pharmaceutical IndustriesIndia | 12 December 2011 |
| 1000 tablet, extended release in 1 bottle | 47335-861-18 | Sun Pharmaceutical IndustriesIndia | 12 December 2011 |
| 30 tablet, extended release in 1 bottle | 47335-861-83 | Sun Pharmaceutical IndustriesIndia | 12 December 2011 |
| 100 tablet, extended release in 1 bottle | 47335-861-88 | Sun Pharmaceutical IndustriesIndia | 12 December 2011 |
| 30 tablet, film coated, extended release in 1 bottle | 33342-271-07 | Macleods PharmaceuticalsIndia | 31 January 2025 |
| 90 tablet, film coated, extended release in 1 bottle | 33342-271-10 | Macleods PharmaceuticalsIndia | 31 January 2025 |
| 100 tablet, film coated, extended release in 1 bottle | 33342-271-11 | Macleods PharmaceuticalsIndia | 31 January 2025 |
| 30 tablet, extended release in 1 bottle | 76420-246-30 | Asclemed | 25 July 2022 |
| 30 tablet, extended release in 1 bottle | 76420-538-30 | Asclemed | 16 February 2023 |
| 60 tablet, extended release in 1 bottle | 76420-538-60 | Asclemed | 16 February 2023 |
| 90 tablet, extended release in 1 bottle | 76420-538-90 | Asclemed | 16 February 2023 |
| 30 tablet, extended release in 1 bottle | 63629-8324-1 | Bryant Ranch Prepack | 22 June 2020 |
| 60 tablet, extended release in 1 bottle | 63629-8324-2 | Bryant Ranch Prepack | 4 October 2021 |
| 90 tablet, extended release in 1 bottle | 63629-8324-3 | Bryant Ranch Prepack | 3 April 2024 |
| 120 tablet, extended release in 1 bottle | 63629-8324-4 | Bryant Ranch Prepack | 3 April 2024 |
| 30 tablet, extended release in 1 bottle | 71335-9670-1 | Bryant Ranch Prepack | 24 March 2023 |
| 60 tablet, extended release in 1 bottle | 71335-9670-2 | Bryant Ranch Prepack | 13 April 2026 |
| 90 tablet, extended release in 1 bottle | 71335-9670-3 | Bryant Ranch Prepack | 6 January 2026 |
| 120 tablet, extended release in 1 bottle | 71335-9670-4 | Bryant Ranch Prepack | 13 April 2026 |
| 30 tablet, extended release in 1 bottle | 71205-569-30 | Proficient Rx | 26 May 2021 |
| 60 tablet, extended release in 1 bottle | 71205-569-60 | Proficient Rx | 26 May 2021 |
| 90 tablet, extended release in 1 bottle | 71205-569-90 | Proficient Rx | 26 May 2021 |
| 30 tablet, extended release in 1 bottle | 71205-656-30 | Proficient Rx | 27 April 2022 |
| 60 tablet, extended release in 1 bottle | 71205-656-60 | Proficient Rx | 27 April 2022 |
| 90 tablet, extended release in 1 bottle | 71205-656-90 | Proficient Rx | 27 April 2022 |
| 30 tablet, extended release in 1 bottle | 80425-0312-1 | Advanced Rx Pharmacy of Tennessee | 7 April 2023 |
| 60 tablet, extended release in 1 bottle | 80425-0312-2 | Advanced Rx Pharmacy of Tennessee | 7 April 2023 |
| 90 tablet, extended release in 1 bottle | 80425-0312-3 | Advanced Rx Pharmacy of Tennessee | 7 April 2023 |
| 30 tablet, extended release in 1 bottle | 72189-521-30 | Direct_Rx | 8 November 2023 |
| 30 tablet, extended release in 1 bottle | 45865-184-30 | Medsource Pharmaceuticals | 28 May 2021 |
| 30 tablet, extended release in 1 bottle | 68071-5078-3 | NuCare Pharmaceuticals,Inc | 1 October 2019 |
| 30 tablet, extended release in 1 bottle, plastic | 70518-2795-0 | Remedyrepack | 24 June 2020 |
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 300 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.