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United States· US:63629-1918_983c388d-45d0-446f-b12d-8fbbae69626d

Omega-3-acid ethyl esters

A medicinal product containing omega-3-acid ethyl esters, registered in United States by Bryant Ranch Prepack.

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…normalisedOmega-3-acid ethyl estersATC—REGISTER NO.US:63629-1918_983c388…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
OMEGA-3-ACID ETHYL ESTERS
Manufacturer
Bryant Ranch Prepack
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
    63629-1918-1
  • ndc11
    6362919181
    120 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-1918-1)

Regulatory notes

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

Same medicine, other countries

Omega-3-acid ethyl esters in 9 other countries

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

All omega-3-acid ethyl esters products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

  • Austria · Omacor, Zodin
  • Belgium · Omacor
  • Bulgaria · Омакор
  • Cyprus · Omacor
  • Germany · Omacor, Zodin
  • Denmark · Lipomeg
  • Estonia · Omacor
  • Spain · Ácidos Omega-3 Strides, Omacor
  • France · Esters Ethyliques D’acides Omega 3 Eg Labo Conseil, Esters Ethyliques D’acides Omega-3 Ibsa
  • United Kingdom (Northern Ireland) · Omacor, Omega 3-Acid-Ethyl Esters Strides Pharma Uk
  • Greece · Becolip, Lipemia Forte
  • Croatia · Dualtis, Omacor
  • Hungary · Omacor
  • Ireland · Omacor, Trimega
  • Italy · Agemo, Eskim
  • Lithuania · Omacor
  • Luxembourg · Omacor
  • Latvia · Omacor
  • Malta · Omacor
  • Netherlands · Omacor
  • Norway · Omacor
  • Poland · Omacor
  • Portugal · Ésteres Etílicos 90 Dos Ácidos Ómega-3 Pharmanel, Omacor
  • Romania · Omacor
  • Sweden · Lipomeg
  • Slovenia · Omacor

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/f20d859b-f2bc-4a4c-accc-07d4ecd1041a
GET /v1/drugs/f20d859b-f2bc-4a4c-accc-07d4ecd1041a?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": "OMEGA-3-ACID ETHYL ESTERS",
  "productndc": "63629-1918",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "dea_schedule": null,
  "strength_unit": "g/1",
  "application_number": "ANDA207420",
  "marketing_category": "ANDA"
}

See everything about omega-3-acid ethyl esters.

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.