United States· US:43598-746_c3a4c4b8-99cb-5e6e-8641-e71a1cc13692

Icosapent Ethyl

A medicinal product containing icosapent ethyl, registered in United States by Dr. Reddy's Laboratories, Inc..

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedIcosapent EthylATC—REGISTER NO.US:43598-746_c3a4c4b8…PACKS LISTED1CHECKEDJuly 19, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ICOSAPENT ETHYL
Manufacturer
Dr. Reddy's Laboratories, Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
July 19, 2026

Packs & prices · 1

  • ndc11
    43598-746-72

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/ee51dc94-e0cf-4a96-888b-117c25e19306
GET /v1/drugs/ee51dc94-e0cf-4a96-888b-117c25e19306?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": "500",
  "substance": "ICOSAPENT ETHYL",
  "productndc": "43598-746",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA209499",
  "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.