Medicine
Tramadol 100 mg tablet
Tramadol 100 mg tablet is a generic prescription medicine for oral use, made by 5 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Tramadol
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1000 tablets, 100 tablets, 500 tablets and 11 more
- Manufacturers
- AsclemedAdvagen PharmaTruPharmaCouplerRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- 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
- 24 February 2020
- Identifiers
- RxCUI 835603, 2179635, 2670390 +1DailyMed set ID 61fb5ba7-6896-4ee4-83de-caee69b06a8e, 6a60bd36-7dcc-49c3-b6de-b263fdaa312c, b5852b90-e415-47ef-8f73-87266b58e033 +2NDC 52817-196, 76420-734, 64980-663 +2Application ANDA208708, ANDA075968
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 |
|---|---|---|---|
| 1000 tablet, coated in 1 bottle | 72888-008-00 | Advagen Pharma | 24 February 2020 |
| 100 tablet, coated in 1 bottle | 72888-008-01 | Advagen Pharma | 24 February 2020 |
| 500 tablet, coated in 1 bottle | 72888-008-05 | Advagen Pharma | 24 February 2020 |
| 100 tablet in 1 bottle | 64980-663-01 | Rising Pharma Holdings | 24 October 2024 |
| 1000 tablet, coated in 1 bottle | 52817-196-00 | Trupharma | 24 February 2020 |
| 100 tablet, coated in 1 bottle | 52817-196-10 | Trupharma | 24 February 2020 |
| 500 tablet, coated in 1 bottle | 52817-196-50 | Trupharma | 24 February 2020 |
| 1000 tablet, coated in 1 bottle | 76420-734-00 | Asclemed | 22 May 2024 |
| 100 tablet, coated in 1 bottle | 76420-734-01 | Asclemed | 22 May 2024 |
| 500 tablet, coated in 1 bottle | 76420-734-05 | Asclemed | 22 May 2024 |
| 30 tablet, coated in 1 bottle | 76420-734-30 | Asclemed | 22 May 2024 |
| 60 tablet, coated in 1 bottle | 76420-734-60 | Asclemed | 22 May 2024 |
| 90 tablet, coated in 1 bottle | 76420-734-90 | Asclemed | 22 May 2024 |
| 30 tablet, coated in 1 blister pack | 67046-1541-3 | Coupler | 25 March 2025 |
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 100 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.