United States· US:0054-0508_8963be4d-11e2-42c9-af2f-410b99a4694f
Icosapent Ethyl
A medicinal product containing icosapent ethyl, 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
- ICOSAPENT ETHYL
- 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
- ndc110054-0508-23
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Icosapent ethyl in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaVASCEPAHLS THERAPEUTICS INC
- Japanイコサペント酸エチル持田製薬
- CzechiaVAZKEPARecordati Industria Chimica e Farmaceutica S.p.A., Milano
- FinlandVazkepaAbacus Medicine A/S
- SwitzerlandVazkepa 998 mg, WeichkapselnRECORDATI AG
- ItalyVAZKEPA*120 cps molli 998 mg flaconeAMARIN PHARMAC IRELAND LIMITED
- NetherlandsVazkepa 998 mg zachte capsulesRecordati Industria Chimica e Farmaceutica S.p.A.
- NorwayVazkepaRecordati Industria Chimica e Farmaceutica S.p.A.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Vazkepa
- Liechtenstein · Vazkepa
- Norway · Vazkepa
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/e9506e2e-3337-4add-97a7-f216e0ceb880 GET /v1/drugs/e9506e2e-3337-4add-97a7-f216e0ceb880?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": "ORAL",
"source": "ndc",
"strength": "1",
"substance": "ICOSAPENT ETHYL",
"productndc": "0054-0508",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "g/1",
"application_number": "ANDA209457",
"marketing_category": "ANDA"
}See everything about icosapent ethyl.
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.