Medicine
Buprenorphine and Naloxone 8 mg/2 mg sublingual tablet
Buprenorphine and Naloxone 8 mg/2 mg sublingual tablet is a generic prescription medicine for sublingual 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).
Key facts
- Active ingredient (INN)
- Buprenorphine and Naloxone
- Brand
- Sold under the generic name
- Strength
- 8 mg/2 mg
- Dosage form
- Sublingual tablet
- Route
- Sublingual
- Packs
- 30 tablets, 3 blister pack, 90 tablets and 80 more
- Manufacturers
- Ascend LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaAccord HealthcareIndiaCamber PharmaceuticalsIndiaBryant Ranch PrepackAmneal PharmaceuticalsActavis PharmaHikma PharmaceuticalsLannettPAI Pharma21 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- ATC code
- N07BC51 Buprenorphine and Naloxone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 February 2013
- Identifiers
- RxCUI 351267, 351266DailyMed set ID 63aaa6cc-8574-4990-8239-6fdeffce92c8, 4f979409-f9a2-d3a2-e063-6394a90accd0, 4f6e0056-b19d-0d0e-e063-6294a90a16e5 +29NDC 71335-2981, 87441-002, 51407-949 +29Application ANDA205601, ANDA207000, ANDA203326 +8
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 83 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle, plastic | 16729-550-10 | Accord HealthcareIndia | 1 September 2020 |
| 30 tablet in 1 bottle | 67877-606-30 | Ascend LaboratoriesIndia | 3 July 2026 |
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 67877-606-84 | Ascend LaboratoriesIndia | 3 July 2026 |
| 90 tablet in 1 bottle | 67877-606-90 | Ascend LaboratoriesIndia | 3 July 2026 |
| 30 tablet in 1 bottle | 31722-851-30 | Camber PharmaceuticalsIndia | 5 January 2026 |
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 62756-970-64 | Sun Pharmaceutical IndustriesIndia | 18 July 2017 |
| 30 tablet in 1 bottle | 62756-970-83 | Sun Pharmaceutical IndustriesIndia | 18 July 2017 |
| 30 tablet in 1 bottle | 0228-3155-03 | Actavis Pharma | 4 March 2013 |
| 30 tablet in 1 bottle | 65162-415-03 | Amneal Pharmaceuticals | 22 February 2013 |
| 90 tablet in 1 bottle | 65162-415-09 | Amneal Pharmaceuticals | 22 February 2013 |
| 30 tablet in 1 bottle | 0054-0189-13 | Hikma Pharmaceuticals | 27 June 2014 |
| 30 tablet in 1 bottle | 62175-458-32 | Lannett | 19 September 2016 |
| 30 tablet in 1 bottle, plastic | 0121-2036-30 | PAI Pharma | 5 September 2023 |
| 30 tablet in 1 bottle, plastic | 42858-602-03 | Rhodes Pharmaceuticals | 13 April 2020 |
| 30 tablet in 1 bottle, plastic | 0406-8020-03 | SpecGx | 13 December 2017 |
| 42 tablet in 1 bottle | 63629-5074-0 | Bryant Ranch Prepack | 2 April 2024 |
| 30 tablet in 1 bottle | 63629-5074-1 | Bryant Ranch Prepack | 2 April 2024 |
| 60 tablet in 1 bottle | 63629-5074-2 | Bryant Ranch Prepack | 2 April 2024 |
| 90 tablet in 1 bottle | 63629-5074-3 | Bryant Ranch Prepack | 2 April 2024 |
| 120 tablet in 1 bottle | 63629-5074-4 | Bryant Ranch Prepack | 2 April 2024 |
| 14 tablet in 1 bottle | 63629-5074-5 | Bryant Ranch Prepack | 2 April 2024 |
| 28 tablet in 1 bottle | 63629-5074-6 | Bryant Ranch Prepack | 2 April 2024 |
| 6 tablet in 1 bottle | 63629-5074-7 | Bryant Ranch Prepack | 2 April 2024 |
| 10 tablet in 1 bottle | 63629-5074-8 | Bryant Ranch Prepack | 2 April 2024 |
| 21 tablet in 1 bottle | 63629-5074-9 | Bryant Ranch Prepack | 2 April 2024 |
| 30 tablet in 1 bottle, plastic | 63629-9483-1 | Bryant Ranch Prepack | 12 December 2022 |
| 42 tablet in 1 bottle | 71335-1378-0 | Bryant Ranch Prepack | 20 May 2024 |
| 30 tablet in 1 bottle | 71335-1378-1 | Bryant Ranch Prepack | 25 October 2019 |
| 60 tablet in 1 bottle | 71335-1378-2 | Bryant Ranch Prepack | 20 May 2024 |
| 90 tablet in 1 bottle | 71335-1378-3 | Bryant Ranch Prepack | 20 May 2024 |
| 120 tablet in 1 bottle | 71335-1378-4 | Bryant Ranch Prepack | 20 May 2024 |
| 14 tablet in 1 bottle | 71335-1378-5 | Bryant Ranch Prepack | 20 May 2024 |
| 28 tablet in 1 bottle | 71335-1378-6 | Bryant Ranch Prepack | 20 May 2024 |
| 6 tablet in 1 bottle | 71335-1378-7 | Bryant Ranch Prepack | 20 May 2024 |
| 10 tablet in 1 bottle | 71335-1378-8 | Bryant Ranch Prepack | 20 May 2024 |
| 21 tablet in 1 bottle | 71335-1378-9 | Bryant Ranch Prepack | 20 May 2024 |
| 42 tablet in 1 bottle | 71335-1725-0 | Bryant Ranch Prepack | 4 April 2024 |
| 30 tablet in 1 bottle | 71335-1725-1 | Bryant Ranch Prepack | 4 April 2024 |
| 60 tablet in 1 bottle | 71335-1725-2 | Bryant Ranch Prepack | 4 April 2024 |
| 90 tablet in 1 bottle | 71335-1725-3 | Bryant Ranch Prepack | 4 April 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.
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 Buprenorphine and Naloxone
Clinical summary
Buprenorphine and Naloxone is a fixed-dose combination of an opioid antagonist and a partial opioid agonist indicated for treatment of opioid dependence. It is available as sublingual tablets, buccal films and orally disintegrating tablets. MedsAcross supplies Buprenorphine and Naloxone 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 Buprenorphine and NaloxoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Suboxone prescribing information (Indivior) · U.S. National Library of Medicine, DailyMed
- Zubsolv: European public assessment report (EPAR) · European Medicines Agency
Need Buprenorphine and Naloxone 8 mg/2 mg sublingual 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.