Medicine
Zubsolv 11.4 mg/2.9 mg orally disintegrating tablet
Zubsolv 11.4 mg/2.9 mg orally disintegrating tablet is a prescription medicine containing Buprenorphine and Naloxone for sublingual use, marketed by Edenbridge Pharmaceuticals, 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 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F) Store…
Key facts
- Active ingredient (INN)
- Buprenorphine and Naloxone
- Brand
- Zubsolv
- Strength
- 11.4 mg/2.9 mg
- Dosage form
- Orally disintegrating tablet
- Route
- Sublingual
- Packs
- 3 blister pack
- Marketing authorisation holder
- Edenbridge Pharmaceuticals
- Manufacturers
- Edenbridge PharmaceuticalsOrexo
- Origin register
- US FDA, United States
- Storage
- Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F) Store ZUBSOLV 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
- 11 December 2014
- Identifiers
- RxCUI 1431076, 1431083, 1431102 +7DailyMed set ID 57583c1d-9c44-4503-917d-68dba7377bd1, 5f5cfcfe-d52b-49e6-8fe4-550477332dd2NDC 82111-206, 54123-114Application NDA204242
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 |
|---|---|---|---|
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 82111-206-30 | Edenbridge Pharmaceuticals | 12 June 2026 |
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 54123-114-30 | Orexo | 11 December 2014 |
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 Zubsolv 11.4 mg/2.9 mg orally disintegrating 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.