Medicine
Belbuca 300 mcg buccal film
Belbuca 300 mcg buccal film is a prescription medicine containing Buprenorphine for buccal use, marketed by BioDelivery Sciences International, 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), with excursions permitted between 15°C…
Key facts
- Active ingredient (INN)
- Buprenorphine
- Brand
- Belbuca
- Strength
- 300 mcg
- Dosage form
- Buccal film
- Route
- Buccal
- Packs
- 60 pouches
- Marketing authorisation holder
- BioDelivery Sciences International
- Manufacturer
- BioDelivery Sciences International
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Store BELBUCA securely and dispose of properly.
- 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
- 1 September 2017
- Identifiers
- RxCUI 1716057, 1716063, 1716065 +7DailyMed set ID bc2b7a3d-72cf-497c-95b0-ba2b71f63c64NDC 59385-023Application NDA207932
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 pouch in 1 carton / 1 film, soluble in 1 pouch | 59385-023-60 | BioDelivery Sciences International | 1 September 2017 |
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 Belbuca 300 mcg 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.