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Brand-name prescription medicine

Vascepa

Generic name: Icosapent ethyl

FDA application holder: Amarin Pharms

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Vascepa?
Vascepa is a brand name of Icosapent ethyl, a prescription medicine. The FDA NDC Directory lists 5 Vascepa products in 2 strengths and forms.
Who makes Vascepa?
Amarin Pharms holds the FDA application for Vascepa (NDA202057, approved July 26, 2012). 1 other company (repackagers or distributors) also list Vascepa products.
Is there a generic or store brand of Vascepa?
Yes. The FDA NDC Directory lists 3 other products with the same active ingredients, strength and form as a Vascepa product, 3 of them generic. Ask your pharmacist whether one is right for you.
Has Vascepa been recalled?
No recall linked to Vascepa products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Vascepa is

Each Vascepa product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Icosapent ethyl · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
icosapent ethyl 1000 mg
capsule (oral)
Vascepa 2 products, 2 companies DailyMed
icosapent ethyl 500 mg
capsule (oral)
Vascepa 1 product, 1 company DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Icosapent ethyl →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Vascepa products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA202057Amarin PharmsJuly 26, 20125

Companies that list Vascepa

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Vascepa products.

Recalls

No recall linked to Vascepa products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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