Icosapent Ethyl
.5 g · Capsule
- Prescription only
- Active substance
- Icosapent Ethyl
- Made by
- Softgel Healthcare Private Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
This information is not included in the verified source. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Icosapent Ethyl). It describes the substance, not this exact product.
Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles.
Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity.
EPA is mainly metabolized by the liver via beta-oxidation similar to dietary fatty acids.
Icosapent ethyl was administered with or following a meal in all clinical studies; no food effect studies were performed.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-25
Safety of the active substance
From the US prescribing label for the same active substance (Icosapent Ethyl). It describes the substance, not this exact product.
- Icosapent ethyl is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | Softgel Healthcare Private Limited |
|---|---|
| Active substance | Icosapent Ethyl |
| Strength | .5 g |
| Form | Capsule |
| Route | Oral |
| Packs | 240 CAPSULE in 1 BOTTLE |
| NDC | 35916-1738 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
27 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Capsule21 products
.5 g6
.5 g · 6 companies
- Amneal Pharmaceuticals LLC
- Camber Pharmaceuticals, Inc.
- Hikma Pharmaceuticals USA Inc.
- Softgel Healthcare Private Limited · this page
- XLCare Pharmaceuticals, Inc.
- Zydus Pharmaceuticals USA Inc.
- 500 mg
- Capsule, Liquid Filled6 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.