Medicine
Buprenorphine 8 mg sublingual tablet
Buprenorphine 8 mg sublingual tablet is a generic prescription medicine for sublingual use, made by 18 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
and Disposal Because of the risks associated with accidental ingestion…
Key facts
- Active ingredient (INN)
- Buprenorphine
- Brand
- Sold under the generic name
- Strength
- 8 mg
- Dosage form
- Sublingual tablet
- Route
- Sublingual
- Packs
- 30 tablets, 3 blister pack, 90 tablets and 61 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaCamber PharmaceuticalsIndiaBryant Ranch PrepackAdvagen PharmaActavis PharmaHikma PharmaceuticalsPAI PharmaRhodes PharmaceuticalsSpecGx18 labelers on the register
- Origin register
- US FDA, United States
- Storage
- and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Buprenorphine Sublingual Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- ATC code
- N02AE01 Buprenorphine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 October 2009
- Identifiers
- RxCUI 351264, 351265, 2747481 +1DailyMed set ID 699638dd-3a53-445f-a545-d0e6eabfe1c9, 3a7418a2-bd6e-4082-b0fe-a5498e7b944a, 1bf8b35a-b769-465c-a2f8-099868dfcd2f +22NDC 72888-183, 58118-0177, 0054-0177 +22Application ANDA090279, ANDA078633, ANDA201760 +5
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 18 labelers. The register lists 64 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle | 31722-871-30 | Camber PharmaceuticalsIndia | 12 January 2026 |
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 62756-460-64 | Sun Pharmaceutical IndustriesIndia | 17 February 2016 |
| 30 tablet in 1 bottle | 62756-460-83 | Sun Pharmaceutical IndustriesIndia | 17 February 2016 |
| 30 tablet in 1 bottle | 0228-3153-03 | Actavis Pharma | 10 April 2015 |
| 30 tablet in 1 bottle | 72888-183-30 | Advagen Pharma | 23 January 2024 |
| 90 tablet in 1 bottle | 72888-183-90 | Advagen Pharma | 23 January 2024 |
| 30 tablet in 1 bottle | 0054-0177-13 | Hikma Pharmaceuticals | 8 October 2009 |
| 30 tablet in 1 bottle | 0121-2038-30 | PAI Pharma | 12 October 2023 |
| 30 tablet in 1 bottle | 42858-502-03 | Rhodes Pharmaceuticals | 25 October 2017 |
| 30 tablet in 1 bottle | 0406-7018-03 | SpecGx | 19 January 2026 |
| 120 tablet in 1 bottle | 71335-1154-0 | Bryant Ranch Prepack | 3 April 2024 |
| 90 tablet in 1 bottle | 71335-1154-1 | Bryant Ranch Prepack | 15 March 2019 |
| 60 tablet in 1 bottle | 71335-1154-2 | Bryant Ranch Prepack | 15 March 2019 |
| 30 tablet in 1 bottle | 71335-1154-3 | Bryant Ranch Prepack | 22 July 2019 |
| 20 tablet in 1 bottle | 71335-1154-4 | Bryant Ranch Prepack | 3 April 2024 |
| 7 tablet in 1 bottle | 71335-1154-5 | Bryant Ranch Prepack | 16 January 2020 |
| 28 tablet in 1 bottle | 71335-1154-6 | Bryant Ranch Prepack | 28 June 2021 |
| 1 tablet in 1 bottle | 71335-1154-7 | Bryant Ranch Prepack | 3 April 2024 |
| 12 tablet in 1 bottle | 71335-1154-8 | Bryant Ranch Prepack | 3 April 2024 |
| 14 tablet in 1 bottle | 71335-1154-9 | Bryant Ranch Prepack | 3 April 2024 |
| 120 tablet in 1 bottle | 71335-1163-0 | Bryant Ranch Prepack | 17 May 2024 |
| 90 tablet in 1 bottle | 71335-1163-1 | Bryant Ranch Prepack | 21 March 2019 |
| 60 tablet in 1 bottle | 71335-1163-2 | Bryant Ranch Prepack | 24 April 2019 |
| 30 tablet in 1 bottle | 71335-1163-3 | Bryant Ranch Prepack | 1 April 2019 |
| 20 tablet in 1 bottle | 71335-1163-4 | Bryant Ranch Prepack | 17 May 2024 |
| 7 tablet in 1 bottle | 71335-1163-5 | Bryant Ranch Prepack | 17 May 2024 |
| 28 tablet in 1 bottle | 71335-1163-6 | Bryant Ranch Prepack | 17 May 2024 |
| 1 tablet in 1 bottle | 71335-1163-7 | Bryant Ranch Prepack | 17 May 2024 |
| 12 tablet in 1 bottle | 71335-1163-8 | Bryant Ranch Prepack | 17 May 2024 |
| 14 tablet in 1 bottle | 71335-1163-9 | Bryant Ranch Prepack | 17 May 2024 |
| 120 tablet in 1 bottle | 71335-3152-0 | Bryant Ranch Prepack | 29 June 2026 |
| 90 tablet in 1 bottle | 71335-3152-1 | Bryant Ranch Prepack | 29 June 2026 |
| 60 tablet in 1 bottle | 71335-3152-2 | Bryant Ranch Prepack | 29 June 2026 |
| 30 tablet in 1 bottle | 71335-3152-3 | Bryant Ranch Prepack | 29 June 2026 |
| 20 tablet in 1 bottle | 71335-3152-4 | Bryant Ranch Prepack | 29 June 2026 |
| 7 tablet in 1 bottle | 71335-3152-5 | Bryant Ranch Prepack | 29 June 2026 |
| 28 tablet in 1 bottle | 71335-3152-6 | Bryant Ranch Prepack | 29 June 2026 |
| 1 tablet in 1 bottle | 71335-3152-7 | Bryant Ranch Prepack | 29 June 2026 |
| 12 tablet in 1 bottle | 71335-3152-8 | Bryant Ranch Prepack | 29 June 2026 |
| 14 tablet in 1 bottle | 71335-3152-9 | Bryant Ranch Prepack | 29 June 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
Clinical summary
Buprenorphine is a partial opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, among other approved uses. MedsAcross supplies Buprenorphine 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 BuprenorphineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Buprenorphine prescribing information (Rhodes Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Buprenorphine Neuraxpharm: European public assessment report (EPAR) · European Medicines Agency
- Buvidal: European public assessment report (EPAR) · European Medicines Agency
Need Buprenorphine 8 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.