United States· US:0641-6030_546a047c-1faf-4751-9e48-079e4c35b6fa

Fentanyl Citrate

A medicinal product containing fentanyl citrate, registered in United States by Hikma Pharmaceuticals USA Inc..

US label

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: FENTANYL CITRATE
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 · 2

ndc11
0641603001
50 mL in 1 VIAL (0641-6030-01)
ndc11
0641-6030-01

Regulatory notes

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

Same medicine, other countries

Fentanyl citrate in 17 other countries

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

All fentanyl citrate 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/b1734d2f-68ac-4e34-9ec8-50d28b7c898b
GET /v1/drugs/b1734d2f-68ac-4e34-9ec8-50d28b7c898b?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": "INTRAVENOUS",
  "source": "ndc",
  "strength": "50",
  "substance": "FENTANYL CITRATE",
  "productndc": "0641-6030",
  "dosage_form": "INJECTION",
  "dea_schedule": "CII",
  "strength_unit": "ug/mL",
  "application_number": "NDA019101",
  "marketing_category": "NDA"
}

API reference MCP server Plans

See everything about fentanyl citrate.

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.

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