United States· US:52937-001_86b35fe3-d1cf-478e-849b-2ea0c87bda33

Vascepa

A medicinal product containing icosapent ethyl, registered in United States by Amarin Pharma 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…normalisedVascepaATC—REGISTER NO.US:52937-001_86b35fe3…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ICOSAPENT ETHYL
Manufacturer
Amarin Pharma 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
    5293700120
    120 CAPSULE in 1 BOTTLE (52937-001-20)
  • ndc11
    52937-001-20

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.

All icosapent ethyl products

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/c1f1a1a1-320a-40da-b64d-b10a0a5425a9
GET /v1/drugs/c1f1a1a1-320a-40da-b64d-b10a0a5425a9?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": "1000",
  "substance": "ICOSAPENT ETHYL",
  "productndc": "52937-001",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA202057",
  "marketing_category": "NDA"
}

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.