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United States· US:0904-7495_b4dad9e0-98b3-4538-bc99-e390185bf642

OMEGA-3-ACID ETHYL ESTERS

A omega-3-fettsäuren inkl. andere ester und säuren (nahrungsergänzungsmittel siehe v06dz) product containing omega-3-acid ethyl esters, registered in United States by Major Pharmaceuticals. The same ATC class is registered in 12 of our 19 countries.

ATC C10AX06Orange BookUS 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 ESTERSATCC10AX06REGISTER NO.US:0904-7495_b4dad9e0…PACKS LISTED1CHECKEDJune 3, 2026

Where it is registered

Omega-3-fettsäuren inkl. andere ester und säuren (nahrungsergänzungsmittel siehe v06dz) is registered in 12 of 19 countries.

Countries holding a registration under ATC C10AX06 (omega-3-fettsäuren inkl. andere ester und säuren (nahrungsergänzungsmittel siehe v06dz)), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 9 of them publish a price we can compare per daily dose

Omega-3-fettsäuren inkl. andere ester und säuren (nahrungsergänzungsmittel siehe v06dz) · ATC C10AX06

12 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of omega-3-fettsäuren inkl. andere ester und säuren (nahrungsergänzungsmittel siehe v06dz) costs, country by country.

Normalised to the WHO defined daily dose (4 g), the median price runs from $0.68 in United States to $1967.31 in Italy — a ×2875 gap.

  • United States: $0.68 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown
  • US figures are pharmacy acquisition cost (CMS NADAC), not retail

Omega-3-fettsäuren inkl. andere ester und säuren (nahrungsergänzungsmittel siehe v06dz) · price per daily dose (4 g)

USD · FX 28 Sept 2026

  • IT Italy$1967.31
  • US United States$0.68 (acquisition cost)
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Omega-3-acid ethyl esters
Manufacturer
Major Pharmaceuticals
Country
United States (US)
ATC code
C10AX06
ATC class
Omega-3-Fettsäuren inkl. andere Ester und Säuren (Nahrungsergänzungsmittel siehe V06DZ)
Defined daily dose
4 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    0904749506
    50 BLISTER PACK in 1 CARTON (0904-7495-06) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Regulatory notes

UNII (FDA substance ID)
D87YGH4Z0Q
OMEGA-3-ACID ETHYL ESTERS
RxCUI 484348
Orange Book
A215458
AB
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Omega-3-fettsäuren inkl. andere ester und säuren (nahrungsergänzungsmittel siehe v06dz) 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-fettsäuren inkl. andere ester und säuren (nahrungsergänzungsmittel siehe v06dz) 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/ba853917-3627-4c04-8118-c5f6e5dc7cae
GET /v1/drugs/ba853917-3627-4c04-8118-c5f6e5dc7cae?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.

{
  "unii": {
    "unii": "D87YGH4Z0Q",
    "rxcui": "484348",
    "inchikey": null,
    "display_name": "OMEGA-3-ACID ETHYL ESTERS",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9499c40e-6665-4fbf-914d-1a9931b93562": {
      "match": "brand_token",
      "title": "OMEGA-3-ACID ETHYL ESTERS CAPSULE [STRIDES PHARMA SCIENCE LIMITED]",
      "spl_version": "7",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0904-7495_b4dad9e0-98b3-4538-bc99-e390185bf642",
  "productndc": "0904-7495",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "215458",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS",
        "product_no": "001",
        "approval_date": "Nov 15, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OMEGA-3-ACID ETHYL ESTERS",
  "proprietary_name": "OMEGA-3-ACID ETHYL ESTERS",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA215458",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omega-3-acid ethyl esters",
  "start_marketing_date": "20241213",
  "active_numerator_strength": "1"
}

See everything about omega-3-fettsäuren inkl. andere ester und säuren (nahrungsergänzungsmittel siehe v06dz).

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.