Medicine
Buprenorphine and Naloxone 2 mg/0.5 mg buccal film
Buprenorphine and Naloxone 2 mg/0.5 mg buccal film is a generic prescription medicine for buccal, sublingual use, made by 6 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Buprenorphine and Naloxone
- Brand
- Sold under the generic name
- Strength
- 2 mg/0.5 mg
- Dosage form
- Buccal film
- Route
- Buccal, sublingual
- Packs
- 30 pouches, 6 pouches and 6 more
- Manufacturers
- Camber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaRedpharm DrugAveva Drug Delivery SystemsIngenus PharmaceuticalsMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store buprenorphine and naloxone sublingual film 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
- 14 June 2018
- Identifiers
- RxCUI 1010600, 1010604, 1307056 +1DailyMed set ID cb112448-49a1-4209-bcdb-7cfae6501f51, 5005a6c8-9a3b-a99a-e063-6294a90aac13, 557d8d4d-8751-431c-b18e-9d5cf23fc579 +4NDC 3215-6521, 67296-2228, 0378-8765 +4Application ANDA212756, ANDA211785, ANDA219850 +1
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 pouch in 1 carton / 1 film, soluble in 1 pouch | 31722-479-30 | Camber PharmaceuticalsIndia | 1 May 2026 |
| 30 pouch in 1 carton / 1 film, soluble in 1 pouch | 43598-579-30 | Dr. Reddy's LaboratoriesIndia | 14 June 2018 |
| 30 pouch in 1 carton / 1 film in 1 pouch | 3215-6521-30 | Aveva Drug Delivery Systems | 7 March 2025 |
| 30 pouch in 1 carton / 1 film in 1 pouch | 50742-397-30 | Ingenus Pharmaceuticals | 8 August 2024 |
| 30 pouch in 1 carton / 1 film in 1 pouch | 0378-8765-93 | Mylan Pharmaceuticals | 17 April 2020 |
| 30 pouch in 1 carton / 1 film in 1 pouch | 67296-2063-3 | Redpharm Drug | 17 April 2020 |
| 6 pouch in 1 carton / 1 film in 1 pouch | 67296-2063-6 | Redpharm Drug | 17 April 2020 |
| 6 pouch in 1 carton / 1 film in 1 pouch | 67296-2228-1 | Redpharm Drug | 8 August 2024 |
| 30 pouch in 1 carton / 1 film in 1 pouch | 67296-2228-3 | Redpharm Drug | 8 August 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
Alternatives
Other makers and brands of Buprenorphine and Naloxone 2 mg/0.5 mg buccal film.
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 buccal film 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.