Medicine
Buprenorphine and Naloxone 2 mg/0.5 mg sublingual tablet
Buprenorphine and Naloxone 2 mg/0.5 mg sublingual tablet is a generic prescription medicine for sublingual use, made by 19 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 Buprenorphine and Naloxone…
Key facts
- Active ingredient (INN)
- Buprenorphine and Naloxone
- Brand
- Sold under the generic name
- Strength
- 2 mg/0.5 mg
- Dosage form
- Sublingual tablet
- Route
- Sublingual
- Packs
- 30 tablets, 3 blister pack, 90 tablets and 31 more
- Manufacturers
- Ascend LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaAccord HealthcareIndiaCamber PharmaceuticalsIndiaBryant Ranch PrepackClinical Solutions WholesaleAmneal PharmaceuticalsActavis PharmaAmerican Health PackagingAvPAK
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store Buprenorphine and Naloxone Sublingual Tablets securely and dispose of properly.
- 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 351266, 351267DailyMed set ID d25b1a73-9794-4e86-82eb-dee3f159a214, 4f979409-f9a2-d3a2-e063-6394a90accd0, fc2755a5-3292-4b49-872d-e22c386a4e44 +24NDC 71335-1653, 87441-003, 71335-1296 +24Application ANDA203326, ANDA207000, ANDA205022 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle, plastic | 16729-549-10 | Accord HealthcareIndia | 1 September 2020 |
| 30 tablet in 1 bottle | 67877-607-30 | Ascend LaboratoriesIndia | 3 July 2026 |
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 67877-607-84 | Ascend LaboratoriesIndia | 3 July 2026 |
| 90 tablet in 1 bottle | 67877-607-90 | Ascend LaboratoriesIndia | 3 July 2026 |
| 30 tablet in 1 bottle | 31722-850-30 | Camber PharmaceuticalsIndia | 5 January 2026 |
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 62756-969-64 | Sun Pharmaceutical IndustriesIndia | 18 July 2017 |
| 30 tablet in 1 bottle | 62756-969-83 | Sun Pharmaceutical IndustriesIndia | 18 July 2017 |
| 30 tablet in 1 bottle | 0228-3154-03 | Actavis Pharma | 4 March 2013 |
| 30 tablet in 1 bottle | 65162-416-03 | Amneal Pharmaceuticals | 22 February 2013 |
| 90 tablet in 1 bottle | 65162-416-09 | Amneal Pharmaceuticals | 22 February 2013 |
| 30 tablet in 1 bottle | 0054-0188-13 | Hikma Pharmaceuticals | 27 June 2014 |
| 30 tablet in 1 bottle | 62175-452-32 | Lannett | 19 September 2016 |
| 30 tablet in 1 bottle, plastic | 0121-1018-30 | PAI Pharma | 5 September 2023 |
| 30 tablet in 1 bottle, plastic | 42858-601-03 | Rhodes Pharmaceuticals | 13 April 2020 |
| 30 tablet in 1 bottle, plastic | 0406-8005-03 | SpecGx | 13 December 2017 |
| 30 tablet in 1 bottle | 63629-7269-1 | Bryant Ranch Prepack | 2 April 2024 |
| 30 tablet in 1 bottle, plastic | 63629-9482-1 | Bryant Ranch Prepack | 12 December 2022 |
| 30 tablet in 1 bottle | 71335-1296-1 | Bryant Ranch Prepack | 12 August 2019 |
| 10 tablet in 1 bottle | 71335-1296-2 | Bryant Ranch Prepack | 17 May 2024 |
| 30 tablet in 1 bottle | 71335-1514-1 | Bryant Ranch Prepack | 17 February 2020 |
| 10 tablet in 1 bottle | 71335-1514-2 | Bryant Ranch Prepack | 21 September 2022 |
| 30 tablet in 1 bottle | 71335-1653-1 | Bryant Ranch Prepack | 29 October 2020 |
| 30 tablet in 1 bottle | 71335-1720-1 | Bryant Ranch Prepack | 19 October 2020 |
| 10 tablet in 1 bottle | 71335-1720-2 | Bryant Ranch Prepack | 12 August 2024 |
| 30 tablet in 1 bottle, plastic | 72162-1346-3 | Bryant Ranch Prepack | 3 April 2026 |
| 30 tablet in 1 blister pack | 58118-0549-8 | Clinical Solutions Wholesale | 5 March 2026 |
| 30 tablet in 1 blister pack | 58118-1188-8 | Clinical Solutions Wholesale | 4 March 2026 |
| 30 tablet in 1 blister pack | 58118-8005-8 | Clinical Solutions Wholesale | 11 July 2023 |
| 50 blister pack in 1 carton / 1 tablet in 1 blister pack | 60687-626-65 | American Health Packaging | 10 March 2022 |
| 50 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 50268-144-15 | AvPAK | 8 December 2016 |
| 30 tablet in 1 bottle | 51407-948-30 | Golden State Medical Supply | 13 April 2026 |
| 50 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-7009-06 | Major Pharmaceuticals | 27 June 2014 |
| 30 tablet in 1 blister pack | 70518-3862-0 | Remedyrepack | 15 September 2023 |
| 30 tablet in 1 blister pack | 87441-003-01 | Unit Dose Solutions | 13 April 2026 |
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 2 mg/0.5 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.