United States· US:0054-0189_9354364e-c65b-460a-b6f9-840ecc2d95a5
buprenorphine and naloxone
A medicinal product containing buprenorphine hydrochloride; naloxone hydrochloride dihydrate, registered in United States by Hikma Pharmaceuticals USA 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; NALOXONE HYDROCHLORIDE DIHYDRATE
- Manufacturer
- Hikma Pharmaceuticals USA 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 · 1
- ndc110054-0189-13
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Buprenorphine hydrochloride; naloxone hydrochloride dihydrate in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaBUPENSANDUOG.L. Pharma GmbH, Lannach
- CanadaPMS-BUPRENORPHINE-NALOXONEPHARMASCIENCE INC
- PolandSuboxoneIndivior Europe Limited
- United KingdomBuprenorphine 2mg / Naloxone 500microgram sublingual tablets sugar freeAlliance Healthcare (Distribution) Ltd
- FinlandBunalictSandoz A/S
- SwedenBunalict 2 mg/0,5 mg Resoriblett, sublingualSandoz A/S
- NetherlandsBunalict 2 mg/0,5 mg, tabletten voor sublinguaal gebruikSandoz B.V.
- SpainBUPRENORFINA/NALOXONA AUROVITAS 2 MG/0,5 MG COMPRIMIDOS SUBLINGUALES EFGAurovitas Spain, S.A.U.
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Bupensan Duo
- Belgium · Libroxar
- Bulgaria · Булнексо
- Cyprus · Libroxar
- Czechia · Bupensanduo, Libroxar
- Germany · Bowielone, Bulnexo
- Denmark · Bunalict, Buprenorphin/Naloxon G.L. Pharma
- Estonia · Bupensanduo
- Spain · Buprenorfina/Naloxona Aurovitas
- Finland · Bunalict, Buprenorphine/Naloxone G.L. Pharma
- France · Buprenorphine / Naloxone Viatris, Buprenorphine/Naloxone Arrow
- United Kingdom (Northern Ireland) · Buprenorphine/Naloxone Ethypharm, Buprenorphine/Naloxone G.L. Pharma
- Greece · Libroxar
- Croatia · Bulnexo, Bunalict
- Hungary · Bulnexo
- Ireland · Bulexin, Buprenorphine/Naloxone Pinewood
- Iceland · Suboxone, Zubsolv
- Italy · Bunamol, Buprenorfina E Naloxone Ethypharm
- Liechtenstein · Suboxone, Zubsolv
- Lithuania · Bupensanduo
- Luxembourg · Libroxar
- Latvia · Bupensanduo
- Malta · Libroxar
- Netherlands · Bunalict, Buprenorfine/Naloxon Viatris
- Norway · Bunalict, Suboxone
- Portugal · Buprenorfina + Naloxona Generis
- Sweden · Bunalict, Buprenorphine/Naloxone G.L. Pharma
- Slovenia · Bulnexo
- Slovakia · Bupensanduo
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/05ba91d9-cc91-4471-a7f0-fe304b345e6d GET /v1/drugs/05ba91d9-cc91-4471-a7f0-fe304b345e6d?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": "SUBLINGUAL",
"source": "ndc",
"strength": "8; 2",
"substance": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
"productndc": "0054-0189",
"dosage_form": "TABLET",
"dea_schedule": "CIII",
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA203326",
"marketing_category": "ANDA"
}See everything about buprenorphine hydrochloride; naloxone hydrochloride dihydrate.
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.