Medicine
Acetaminophen and Oxycodone 325 mg/10 mg tablet
Acetaminophen and Oxycodone 325 mg/10 mg tablet is a generic prescription medicine for oral use, made by 21 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). Protect from moisture. Store Oxycodone and…
Key facts
- Active ingredient (INN)
- Acetaminophen and Oxycodone
- Brand
- Sold under the generic name
- Strength
- 325 mg/10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 145 more
- Manufacturers
- Aurolife PharmaIndiaCamber PharmaceuticalsIndiaGranules IndiaIndiaLupinIndiaBryant Ranch PrepackSpecGxAlvogenKVK-TechRhodes PharmaceuticalsAmneal Pharmaceuticals of New York21 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from moisture. Store Oxycodone and Acetaminophen Tablets securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 June 2004
- Identifiers
- RxCUI 1049214, 1049221, 1049225 +3DailyMed set ID 5999f3c3-3225-4d24-82cd-0b8d7a309587, d61e0ff4-e04b-4dc6-b818-6a8f46e99b5e, 639aba0b-1ef6-415f-9732-ebf52bcc1b86 +35NDC 42858-104, 53746-204, 63629-8876 +35Application ANDA201278, ANDA040778, ANDA207419 +9
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 21 labelers. The register lists 148 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 31722-194-01 | Camber PharmaceuticalsIndia | 11 April 2017 |
| 500 tablet in 1 bottle | 31722-194-05 | Camber PharmaceuticalsIndia | 11 April 2017 |
| 100 tablet in 1 bottle | 31722-951-01 | Camber PharmaceuticalsIndia | 15 March 2019 |
| 500 tablet in 1 bottle | 31722-951-05 | Camber PharmaceuticalsIndia | 15 March 2019 |
| 100 tablet in 1 bottle | 13107-046-01 | Aurolife PharmaIndia | 15 July 2013 |
| 500 tablet in 1 bottle | 13107-046-05 | Aurolife PharmaIndia | 15 July 2013 |
| 30 tablet in 1 bottle | 13107-046-30 | Aurolife PharmaIndia | 15 July 2013 |
| 1000 tablet in 1 bottle | 13107-046-99 | Aurolife PharmaIndia | 15 July 2013 |
| 100 tablet in 1 bottle | 70010-670-01 | Granules IndiaIndia | 1 January 2022 |
| 500 tablet in 1 bottle | 70010-670-05 | Granules IndiaIndia | 1 January 2022 |
| 100 tablet in 1 bottle | 43386-493-01 | LupinIndia | 24 February 2017 |
| 500 tablet in 1 bottle | 43386-493-05 | LupinIndia | 24 February 2017 |
| 100 tablet in 1 bottle | 47781-230-01 | Alvogen | 17 January 2012 |
| 500 tablet in 1 bottle | 47781-230-05 | Alvogen | 17 January 2012 |
| 250 tablet in 1 bottle | 47781-230-63 | Alvogen | 17 January 2012 |
| 100 tablet in 1 bottle | 53746-204-01 | Amneal Pharmaceuticals of New York | 27 November 2007 |
| 500 tablet in 1 bottle | 53746-204-05 | Amneal Pharmaceuticals of New York | 27 November 2007 |
| 100 tablet in 1 bottle | 64850-623-01 | Elite Laboratories | 4 December 2017 |
| 500 tablet in 1 bottle | 64850-623-05 | Elite Laboratories | 9 April 2026 |
| 100 tablet in 1 bottle | 42806-116-01 | Epic Pharma | 2 July 2018 |
| 100 tablet in 1 bottle | 71930-047-12 | Eywa Pharma | 1 June 2019 |
| 500 tablet in 1 bottle | 71930-047-52 | Eywa Pharma | 1 June 2019 |
| 100 tablet in 1 bottle | 10702-187-01 | KVK-Tech | 9 February 2018 |
| 1000 tablet in 1 bottle | 10702-187-10 | KVK-Tech | 9 February 2018 |
| 500 tablet in 1 bottle | 10702-187-50 | KVK-Tech | 9 February 2018 |
| 100 tablet in 1 bottle, plastic | 42858-104-01 | Rhodes Pharmaceuticals | 28 August 2014 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 42858-104-10 | Rhodes Pharmaceuticals | 28 August 2014 |
| 500 tablet in 1 bottle, plastic | 42858-104-50 | Rhodes Pharmaceuticals | 28 August 2014 |
| 100 tablet in 1 bottle | 0406-0523-01 | SpecGx | 30 June 2004 |
| 500 tablet in 1 bottle | 0406-0523-05 | SpecGx | 30 June 2004 |
| 1 tablet in 1 blister pack | 0406-0523-23 | SpecGx | 30 June 2004 |
| 100 tablet in 1 blister pack | 0406-0523-62 | SpecGx | 30 June 2004 |
| 100 tablet in 1 bottle | 72865-116-01 | XLCare Pharmaceuticals | 15 March 2019 |
| 500 tablet in 1 bottle | 72865-116-05 | XLCare Pharmaceuticals | 15 March 2019 |
| 30 tablet in 1 bottle | 63629-8834-1 | Bryant Ranch Prepack | 6 October 2021 |
| 120 tablet in 1 bottle | 63629-8834-2 | Bryant Ranch Prepack | 26 October 2021 |
| 90 tablet in 1 bottle | 63629-8834-3 | Bryant Ranch Prepack | 7 October 2021 |
| 28 tablet in 1 bottle | 63629-8834-4 | Bryant Ranch Prepack | 15 March 2023 |
| 60 tablet in 1 bottle | 63629-8834-5 | Bryant Ranch Prepack | 6 October 2021 |
| 20 tablet in 1 bottle | 63629-8834-6 | Bryant Ranch Prepack | 15 March 2023 |
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 11 March 2014 | 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 Acetaminophen and Oxycodone 325 mg/10 mg tablet.
Other strengths and forms of Acetaminophen and Oxycodone
Clinical summary
Acetaminophen and Oxycodone is a fixed-dose combination medicine indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. MedsAcross supplies Acetaminophen and Oxycodone 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 OxycodoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Oxycodone and Acetaminophen prescribing information (Granules India) · U.S. National Library of Medicine, DailyMed
Need Acetaminophen and Oxycodone 325 mg/10 mg tablet for your hospital or patient?
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