Medicine
Acetaminophen and Codeine 300 mg/60 mg tablet
Acetaminophen and Codeine 300 mg/60 mg tablet is a generic prescription medicine for oral use, made by 14 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 acetaminophen and codeine phosphate tablets at 20° to 25°C (68° to 77°F)…
Key facts
- Active ingredient (INN)
- Acetaminophen and Codeine
- Brand
- Sold under the generic name
- Strength
- 300 mg/60 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 79 more
- Manufacturers
- Aurolife PharmaIndiaStrides PharmaIndiaBryant Ranch PrepackElite LaboratoriesEywa PharmaSpecGx14 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store acetaminophen and codeine phosphate tablets at 20° to 25°C (68° to 77°F) Dispense in tight, light-resistant container as defined in the USP. Store acetaminophen and codeine phosphate tablets securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 May 2001
- Identifiers
- RxCUI 993890, 993781, 993770DailyMed set ID 3698e0ff-6a1c-e1ad-e063-6294a90a163a, 4c966d73-77c6-4514-954e-57aa06a080c6, 3e41e55f-7e41-4653-aadb-32a9e47962d9 +19NDC 80425-0530, 70518-2764, 71335-2818 +19Application ANDA212418, ANDA211610, ANDA089828 +2
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 14 labelers. The register lists 82 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 13107-060-01 | Aurolife PharmaIndia | 15 April 2013 |
| 500 tablet in 1 bottle | 13107-060-05 | Aurolife PharmaIndia | 15 April 2013 |
| 30 tablet in 1 bottle | 13107-060-30 | Aurolife PharmaIndia | 15 April 2013 |
| 1000 tablet in 1 bottle | 13107-060-99 | Aurolife PharmaIndia | 15 April 2013 |
| 100 tablet in 1 bottle | 64380-447-01 | Strides PharmaIndia | 20 May 2024 |
| 500 tablet in 1 bottle | 64380-447-02 | Strides PharmaIndia | 20 May 2024 |
| 100 tablet in 1 bottle | 64850-643-01 | Elite Laboratories | 3 May 2024 |
| 500 tablet in 1 bottle | 64850-643-05 | Elite Laboratories | 10 February 2025 |
| 120 tablet in 1 bottle | 64850-643-12 | Elite Laboratories | 10 September 2019 |
| 100 tablet in 1 bottle | 71930-056-12 | Eywa Pharma | 2 August 2019 |
| 500 tablet in 1 bottle | 71930-056-52 | Eywa Pharma | 2 August 2019 |
| 100 tablet in 1 bottle | 0406-0485-01 | SpecGx | 31 May 2001 |
| 500 tablet in 1 bottle | 0406-0485-05 | SpecGx | 31 May 2001 |
| 500 tablet in 1 bottle | 63629-1190-1 | Bryant Ranch Prepack | 2 August 2019 |
| 100 tablet in 1 bottle | 63629-3031-0 | Bryant Ranch Prepack | 25 March 2021 |
| 30 tablet in 1 bottle | 63629-3031-1 | Bryant Ranch Prepack | 18 July 2006 |
| 120 tablet in 1 bottle | 63629-3031-2 | Bryant Ranch Prepack | 2 February 2006 |
| 60 tablet in 1 bottle | 63629-3031-3 | Bryant Ranch Prepack | 18 July 2006 |
| 90 tablet in 1 bottle | 63629-3031-4 | Bryant Ranch Prepack | 3 January 2007 |
| 40 tablet in 1 bottle | 63629-3031-5 | Bryant Ranch Prepack | 29 April 2009 |
| 20 tablet in 1 bottle | 63629-3031-6 | Bryant Ranch Prepack | 1 March 2011 |
| 112 tablet in 1 bottle | 63629-3031-7 | Bryant Ranch Prepack | 15 February 2012 |
| 84 tablet in 1 bottle | 63629-3031-8 | Bryant Ranch Prepack | 15 February 2012 |
| 15 tablet in 1 bottle | 63629-3031-9 | Bryant Ranch Prepack | 9 February 2022 |
| 100 tablet in 1 bottle | 71335-0336-0 | Bryant Ranch Prepack | 9 August 2024 |
| 30 tablet in 1 bottle | 71335-0336-1 | Bryant Ranch Prepack | 9 May 2018 |
| 120 tablet in 1 bottle | 71335-0336-2 | Bryant Ranch Prepack | 9 August 2024 |
| 60 tablet in 1 bottle | 71335-0336-3 | Bryant Ranch Prepack | 12 February 2018 |
| 90 tablet in 1 bottle | 71335-0336-4 | Bryant Ranch Prepack | 9 August 2024 |
| 40 tablet in 1 bottle | 71335-0336-5 | Bryant Ranch Prepack | 9 August 2024 |
| 20 tablet in 1 bottle | 71335-0336-6 | Bryant Ranch Prepack | 29 March 2018 |
| 112 tablet in 1 bottle | 71335-0336-7 | Bryant Ranch Prepack | 9 August 2024 |
| 84 tablet in 1 bottle | 71335-0336-8 | Bryant Ranch Prepack | 9 August 2024 |
| 15 tablet in 1 bottle | 71335-0336-9 | Bryant Ranch Prepack | 9 August 2024 |
| 100 tablet in 1 bottle | 71335-1846-0 | Bryant Ranch Prepack | 7 October 2024 |
| 30 tablet in 1 bottle | 71335-1846-1 | Bryant Ranch Prepack | 7 July 2021 |
| 120 tablet in 1 bottle | 71335-1846-2 | Bryant Ranch Prepack | 7 October 2024 |
| 60 tablet in 1 bottle | 71335-1846-3 | Bryant Ranch Prepack | 15 June 2021 |
| 90 tablet in 1 bottle | 71335-1846-4 | Bryant Ranch Prepack | 15 June 2021 |
| 40 tablet in 1 bottle | 71335-1846-5 | Bryant Ranch Prepack | 7 October 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 | Approved | 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 Acetaminophen and Codeine
Clinical summary
Acetaminophen and Codeine is a fixed-dose combination medicine indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. MedsAcross supplies Acetaminophen and Codeine 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 CodeineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ACETAMINOPHEN AND CODEINE PHOSPHATE prescribing information (Eywa Pharma) · U.S. National Library of Medicine, DailyMed
Need Acetaminophen and Codeine 300 mg/60 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.