Active ingredient
Icosapent Ethyl
40 finished FDA listings contain Icosapent Ethyl as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ICOSAPENT ETHYL
- Dosage forms
- Capsule, Capsule, Liquid Filled
- Routes
- Oral
- Manufacturers / labelers
- 19
- Strengths listed
- .5 g/1 · 1 g/1 · 1 g/g · 1000 mg/1 · 500 mg/1
- Brand names in FDA listings
- Icosapent, Icosapent Ethyl, Vascepa
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1304974
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 202057 | AMARIN PHARMS | 2012-07-26 | 5 |
| ANDA 209457 | HIKMA | 2020-05-21 | 7 |
| ANDA 209499 | DR REDDYS | 2020-08-07 | 3 |
| ANDA 209525 | TEVA PHARMS USA | 2020-09-11 | 2 |
| ANDA 209437 | APOTEX | 2021-06-30 | 3 |
| ANDA 217656 | ZYDUS LIFESCIENCES | 2023-04-20 | 4 |
| ANDA 217844 | ONESOURCE | 2023-09-22 | 2 |
| ANDA 216811 | ASCENT PHARMS INC | 2023-12-07 | 6 |
| ANDA 217919 | HUMANWELL PURACAP | 2023-12-22 | 4 |
| ANDA 218899 | QILU | 2024-11-20 | 1 |
| ANDA 218994 | TORRENT | 2024-12-20 | 1 |
| ANDA 219156 | XIAMEN LP PHARM CO | 2025-08-06 | 1 |
| ANDA 218949 | AUROBINDO PHARMA LTD | 2026-06-24 | 1 |
Official labeling on DailyMed
- ICOSAPENT ETHYL CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS, INC.] · version 8 · 2026-08-31
- ICOSAPENT ETHYL CAPSULE [BRYANT RANCH PREPACK] · version 101 · 2026-08-28
- ICOSAPENT ETHYL CAPSULE [BRYANT RANCH PREPACK] · version 101 · 2026-08-27
- ICOSAPENT ETHYL CAPSULE [BRYANT RANCH PREPACK] · version 2 · 2026-08-27
- ICOSAPENT ETHYL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 2 · 2026-08-25
- ICOSAPENT (ICOSAPENT ETHYL) CAPSULE [BRYANT RANCH PREPACK] · version 103 · 2026-08-14
- ICOSAPENT ETHYL CAPSULE [BRYANT RANCH PREPACK] · version 103 · 2026-08-14
- ICOSAPENT ETHYL CAPSULE [NORTHSTAR RX LLC] · version 4 · 2026-07-30
- ICOSAPENT ETHYL CAPSULE [DR. REDDY'S LABORATORIES, INC.] · version 6 · 2026-07-24
- ICOSAPENT (ICOSAPENT ETHYL) CAPSULE [DR. REDDY'S LABORATORIES, INC.] · version 5 · 2026-07-24
- ICOSAPENT ETHYL CAPSULE [SOFTGEL HEALTHCARE PRIVATE LIMITED] · version 2 · 2026-07-13
- ICOSAPENT ETHYL CAPSULE [HIKMA PHARMACEUTICALS USA INC.] · version 5 · 2026-07-13
Showing the 12 most recent of 28 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.