United States· US:65162-034_605495d0-a1f3-490f-b32d-0ac015c034a0
Omega-3-Acid Ethyl Esters
A medicinal product containing omega-3-acid ethyl esters, registered in United States by Amneal Pharmaceuticals LLC.
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
- OMEGA-3-ACID ETHYL ESTERS
- Manufacturer
- Amneal Pharmaceuticals LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 26, 2026
Packs & prices · 6
- ndc1165162-034-06
- ndc1165162-034-16
- ndc1165162-034-32
- ndc11651620340660 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06)
- ndc116516203416120 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-16)
- ndc116516203432360 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-32)
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.
- PolandOmacorInPharm Sp. z o.o.
- IrelandOmacor 1000 mg Soft CapsulesBASF AS
- NorwayOmacor2care4 ApS
- ItalyOLEVIAIBSA FARMACEUTICI ITALIA S.R.L.
- BelgiumOmacor 1000 mgBASF
- SwedenLipomeg 1000 mg Kapsel, mjukStrides Pharma (Cyprus) Limited
- Japanオメガ－３脂肪酸エチル森下仁丹
- GermanyOmacorBasf As
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/d8098e73-5f09-48c3-953f-6a0a696ff7cf GET /v1/drugs/d8098e73-5f09-48c3-953f-6a0a696ff7cf?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": "65162-034",
"dosage_form": "CAPSULE, LIQUID FILLED",
"dea_schedule": null,
"strength_unit": "g/1",
"application_number": "ANDA204940",
"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.