United States· US:62756-459_ba293490-0f6f-4400-82cd-3af9774839e8
Buprenorphine
A medicinal product containing buprenorphine hydrochloride, registered in United States by Sun Pharmaceutical Industries, 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
- Sun Pharmaceutical Industries, 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 · 4
- ndc1162756-459-64
- ndc1162756-459-83
- ndc1162756459643 BLISTER PACK in 1 CARTON (62756-459-64) / 10 TABLET in 1 BLISTER PACK
- ndc11627564598330 TABLET in 1 BOTTLE (62756-459-83)
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.
- United KingdomBuprenorphine 2mg sublingual tablets sugar freeAccord-UK Ltd
- CzechiaADDNOKI-GEN, LDA, Caparica
- FranceBUPENSAN 2 mg, comprimé sublingualG.L. PHARMA (AUTRICHE)
- BelgiumLibroxar 2 mg - 0.5 mgLaboratoires S.M.B.
- NetherlandsBuprenorfine SUN 2 mg tabletten voor sublinguaal gebruikSun Pharmaceutical Industries Europe B.V.
- PolandBunorfinL.Molteni & C. dei F.lli Alitti Societa di Esercizio S.p.A.
- IrelandBuprenorphine 2 mg Sublingual TabletsActivase Pharmaceuticals Limited
- SwedenBuprefarm 10 mikrogram/timme DepotplåsterOrifarm Generics A/S
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/5f9ed0a3-6e23-47ae-aa5c-9af0de39c77c GET /v1/drugs/5f9ed0a3-6e23-47ae-aa5c-9af0de39c77c?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": "2",
"substance": "BUPRENORPHINE HYDROCHLORIDE",
"productndc": "62756-459",
"dosage_form": "TABLET",
"dea_schedule": "CIII",
"strength_unit": "mg/1",
"application_number": "ANDA201760",
"marketing_category": "ANDA"
}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.