United States· US:0093-3658_192dd133-b93c-43a0-80be-550b6e771c4f

Buprenorphine

A medicinal product containing buprenorphine, registered in United States by Teva Pharmaceuticals USA, Inc..

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedBuprenorphineATC—REGISTER NO.US:0093-3658_192dd133…PACKS LISTED1CHECKEDSeptember 12, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Buprenorphine
Manufacturer
Teva 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 12, 2026

Packs & prices · 1

  • ndc11
    0093365840
    4 POUCH in 1 CARTON (0093-3658-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Buprenorphine in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All buprenorphine products

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/d2f2ca52-b893-4e0e-a937-fcca1ac81920
GET /v1/drugs/d2f2ca52-b893-4e0e-a937-fcca1ac81920?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": "TRANSDERMAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 2
  },
  "productid": "0093-3658_192dd133-b93c-43a0-80be-550b6e771c4f",
  "productndc": "0093-3658",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE",
  "proprietary_name": "Buprenorphine",
  "active_ingred_unit": "ug/h",
  "application_number": "ANDA204937",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buprenorphine",
  "start_marketing_date": "20181126",
  "active_numerator_strength": "15"
}

See everything about buprenorphine.

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.