Medicine
Acetaminophen and Tramadol 325 mg/37.5 mg tablet
Acetaminophen and Tramadol 325 mg/37.5 mg 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 20° to 25°C (68° to 77°F). Store tramadol hydrochloride and…
Key facts
- Active ingredient (INN)
- Acetaminophen and Tramadol
- Brand
- Sold under the generic name
- Strength
- 325 mg/37.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 47 more
- Manufacturers
- Aurobindo PharmaIndiaBryant Ranch PrepackAsclemedAmneal Pharmaceuticals of New YorkDirect_RxProficient Rx11 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store tramadol hydrochloride and acetaminophen tablets USP securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 December 2009
- Identifiers
- RxCUI 836395DailyMed set ID 5058c2b0-5c66-4cd2-80a6-7a4678c1fd51, e8a7c995-e473-ca87-e053-2995a90a5b80, d51600e2-2f73-483c-9b2e-f142bafff16d +13NDC 70518-4461, 72189-382, 53746-617 +13Application ANDA207152, ANDA090485, ANDA201952
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 11 labelers. The register lists 50 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 | 65862-922-01 | Aurobindo PharmaIndia | 22 March 2017 |
| 500 tablet, film coated in 1 bottle | 65862-922-05 | Aurobindo PharmaIndia | 22 March 2017 |
| 30 tablet, film coated in 1 bottle | 65862-922-30 | Aurobindo PharmaIndia | 22 March 2017 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-922-78 | Aurobindo PharmaIndia | 22 March 2017 |
| 1000 tablet, film coated in 1 bottle | 65862-922-99 | Aurobindo PharmaIndia | 22 March 2017 |
| 100 tablet in 1 bottle | 53746-617-01 | Amneal Pharmaceuticals of New York | 17 December 2009 |
| 500 tablet in 1 bottle | 53746-617-05 | Amneal Pharmaceuticals of New York | 17 December 2009 |
| 1000 tablet in 1 bottle | 53746-617-10 | Amneal Pharmaceuticals of New York | 17 December 2009 |
| 30 tablet in 1 bottle | 53746-617-30 | Amneal Pharmaceuticals of New York | 17 December 2009 |
| 30 tablet in 1 bottle | 71335-0111-1 | Bryant Ranch Prepack | 17 March 2021 |
| 60 tablet in 1 bottle | 71335-0111-2 | Bryant Ranch Prepack | 14 April 2021 |
| 90 tablet in 1 bottle | 71335-0111-3 | Bryant Ranch Prepack | 20 August 2021 |
| 120 tablet in 1 bottle | 71335-0111-4 | Bryant Ranch Prepack | 26 September 2022 |
| 20 tablet in 1 bottle | 71335-0111-5 | Bryant Ranch Prepack | 14 April 2021 |
| 40 tablet in 1 bottle | 71335-0111-6 | Bryant Ranch Prepack | 26 September 2022 |
| 100 tablet in 1 bottle | 71335-0111-7 | Bryant Ranch Prepack | 26 September 2022 |
| 15 tablet in 1 bottle | 71335-0111-8 | Bryant Ranch Prepack | 26 September 2022 |
| 30 tablet, film coated in 1 bottle | 71335-1742-1 | Bryant Ranch Prepack | 28 December 2020 |
| 60 tablet, film coated in 1 bottle | 71335-1742-2 | Bryant Ranch Prepack | 26 January 2021 |
| 90 tablet, film coated in 1 bottle | 71335-1742-3 | Bryant Ranch Prepack | 5 March 2021 |
| 120 tablet, film coated in 1 bottle | 71335-1742-4 | Bryant Ranch Prepack | 8 March 2023 |
| 20 tablet, film coated in 1 bottle | 71335-1742-5 | Bryant Ranch Prepack | 3 May 2023 |
| 40 tablet, film coated in 1 bottle | 71335-1742-6 | Bryant Ranch Prepack | 5 April 2024 |
| 100 tablet, film coated in 1 bottle | 71335-1742-7 | Bryant Ranch Prepack | 5 April 2024 |
| 15 tablet, film coated in 1 bottle | 71335-1742-8 | Bryant Ranch Prepack | 5 April 2024 |
| 100 tablet, film coated in 1 bottle | 72162-2510-1 | Bryant Ranch Prepack | 22 March 2017 |
| 1 tablet, film coated in 1 bottle | 76420-105-01 | Asclemed | 30 October 2020 |
| 2 tablet, film coated in 1 bottle | 76420-105-02 | Asclemed | 30 October 2020 |
| 3 tablet, film coated in 1 bottle | 76420-105-03 | Asclemed | 30 October 2020 |
| 10 tablet, film coated in 1 bottle | 76420-105-10 | Asclemed | 30 October 2020 |
| 30 tablet, film coated in 1 bottle | 76420-105-30 | Asclemed | 30 October 2020 |
| 1 tablet in 1 bottle | 76420-983-01 | Asclemed | 14 January 2022 |
| 2 tablet in 1 bottle | 76420-983-02 | Asclemed | 14 January 2022 |
| 3 tablet in 1 bottle | 76420-983-03 | Asclemed | 14 January 2022 |
| 10 tablet in 1 bottle | 76420-983-10 | Asclemed | 14 January 2022 |
| 30 tablet in 1 bottle | 76420-983-30 | Asclemed | 14 January 2022 |
| 60 tablet, film coated in 1 bottle | 72189-382-60 | Direct_Rx | 14 September 2022 |
| 60 tablet in 1 bottle | 72189-671-60 | Direct_rx | 30 March 2026 |
| 30 tablet in 1 bottle | 63187-084-30 | Proficient Rx | 1 January 2019 |
| 60 tablet in 1 bottle | 63187-084-60 | Proficient Rx | 1 January 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 15 August 2001 | 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
Clinical summary
Acetaminophen and Tramadol is a fixed-dose combination medicine indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, among other approved uses. MedsAcross supplies Acetaminophen and 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 Acetaminophen and 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 and Acetaminophen prescribing information (Amneal Pharmaceuticals of New York) · U.S. National Library of Medicine, DailyMed
Need Acetaminophen and Tramadol 325 mg/37.5 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.