United States· US:59385-025_16403e7a-5881-43d2-990c-a7d673971c3d
BELBUCA
A medicinal product containing buprenorphine hydrochloride, registered in United States by BioDelivery Sciences International Inc.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- BioDelivery Sciences International Inc
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1159385-025-60
- ndc11593850256060 POUCH in 1 CARTON (59385-025-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-025-01)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Buprenorphine hydrochloride in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaADDNOKI-GEN, LDA, Caparica
- United KingdomBunov 10micrograms/hour transdermal patchesGlenmark Pharmaceuticals Europe Ltd
- SwedenBuprefarm 10 mikrogram/timme DepotplåsterOrifarm Generics A/S
- FinlandBupaq Multidose vetVetViva Richter GmbH
- NetherlandsBuprenorfine G.L. Pharma 0,2 mg tabletten voor sublinguaal gebruikG.L. Pharma GmbH
- GermanyAcimaphinLuye Pharma Ag
- BelgiumBuprenorfine Sandoz 35 µg/hSandoz
- FranceBUPENSAN 2 mg, comprimé sublingualG.L. PHARMA (AUTRICHE)
Authorised across Europe · EMA
The same active substance is authorised in 28 EEA countries. Names it is sold under:
- Austria · Astec, Bupensan
- Belgium · Temgesic, Transtec
- Bulgaria · Бупренорфин G.L., Бупренорфин Актавис
- Cyprus · Buvera
- Czechia · Addnok, Buprenorfin Stada
- Germany · Acimaphin, Acinorphin
- Denmark · Buprefarm, Bupremyl
- Estonia · Buprenorphine G.L. Pharma
- Spain · Buprenorfina Andrómaco, Buprenorfina Sandoz
- Finland · Buprefarm, Bupremyl
- France · Bupensan, Buprenorphine Arrow
- United Kingdom (Northern Ireland) · Addnok, Bunov
- Greece · Buprenal, Buvera
- Croatia · Buprenorfin Alkaloid, Buprenorfin Sandoz
- Ireland · Buprenorphine Activase Pharmaceuticals, Buprenorphine Morningside Healthcare
- Iceland · Buprenorphine Alvogen, Buprenorphine Neuraxpharm
- Italy · Buprenorfina Molteni, Buprenorfina Sandoz
- Liechtenstein · Buprenorphine Neuraxpharm, Buvidal
- Luxembourg · Temgesic, Temgesic Sublingualis
- Latvia · Buprenorphine G.L. Pharma
- Malta · Buprenorphine Aspire Pharma (Malta), Natzon
- Netherlands · Buprenorfine, Buprenorfine 1a Pharma
- Norway · Bugnanto, Buprefarm
- Poland · Bunondol, Bunorfin
- Portugal · Buprenorfina, Buprenorfina Aurovitas
- Sweden · Buprefarm, Buprenorfin Actavis
- Slovenia · Addnok, Buprenorfin Alkaloid-Int
- Slovakia · Bupretec, Noprex
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/2c4e5fd2-a533-44e0-8874-b6911adb1937 GET /v1/drugs/2c4e5fd2-a533-44e0-8874-b6911adb1937?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "BUCCAL",
"source": "ndc",
"strength": "600",
"substance": "BUPRENORPHINE HYDROCHLORIDE",
"productndc": "59385-025",
"dosage_form": "FILM, SOLUBLE",
"dea_schedule": "CIII",
"strength_unit": "ug/1",
"application_number": "NDA207932",
"marketing_category": "NDA"
}See everything about buprenorphine hydrochloride.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.