United States· US:47781-428_4b8493ea-0ce4-6949-e063-6294a90a8861

Fentanyl system

A medicinal product containing fentanyl, registered in United States by ALVOGEN.

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…normalisedFentanyl systemATC—REGISTER NO.US:47781-428_4b8493ea…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
FENTANYL
Manufacturer
ALVOGEN
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

  • ndc11
    47781-428-47
  • ndc11
    4778142847
    5 POUCH in 1 CARTON (47781-428-47) / 1 PATCH in 1 POUCH (47781-428-11)

Regulatory notes

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

Same medicine, other countries

Fentanyl in 17 other countries

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

All fentanyl products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Actiq, Durogesic
  • Belgium · Durogesic, Fentanyl Matrix Eg
  • Bulgaria · Fentadolor, Sublifen
  • Cyprus · Abstral, Lavifent
  • Czechia · Adolor, Dolforin
  • Germany · Abstral, Actiq
  • Denmark · Abstral, Actiq
  • Estonia · Fentanyl Basi, Fentanyl Kalceks
  • Spain · Abattra, Abfentiq
  • Finland · Durogesic, Fentanyl Basi
  • France · Abstral, Actiq
  • United Kingdom (Northern Ireland) · Abstral, Actiq
  • Greece · Abstral, Actiq
  • Croatia · Durogesic, Fentanil Kalceks
  • Hungary · Dolforin, Durogesic
  • Ireland · Abstral, Actiq
  • Iceland · Durogesic, Fentanyl Actavis
  • Italy · Abstral, Actiq
  • Liechtenstein · Pecfent
  • Lithuania · Dolforin, Fentanyl Kalceks
  • Luxembourg · Durogesic, Fentanyl Hameln
  • Latvia · Dolforin, Fentanyl Citrate Kalceks
  • Malta · Fentadur, Fentanyl Kalceks
  • Netherlands · Abstral, Actiq
  • Norway · Abstral, Durogesic
  • Poland · Aurofena, Durogesic
  • Portugal · Abstral, Actiq
  • Romania · Fentanil Kalceks, Fentanyl Lavipharm
  • Sweden · Abstral, Actiq
  • Slovenia · Durogesic, Epufen
  • Slovakia · Breakyl, Fentanyl Kalceks

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/d0a7afeb-9181-464c-a7e0-6c1cbf996841
GET /v1/drugs/d0a7afeb-9181-464c-a7e0-6c1cbf996841?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",
  "source": "ndc",
  "strength": "100",
  "substance": "FENTANYL",
  "productndc": "47781-428",
  "dosage_form": "PATCH",
  "dea_schedule": "CII",
  "strength_unit": "ug/1",
  "application_number": "ANDA202097",
  "marketing_category": "ANDA"
}

See everything about fentanyl.

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.