Active ingredient
Omega-3 Acid Ethyl Esters (Usp)
26 finished FDA listings contain Omega-3 Acid Ethyl Esters (Usp) as their only active ingredient; 1 combination products also contain it.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- OMEGA-3-ACID ETHYL ESTERS
- Dosage forms
- Capsule, Capsule, Liquid Filled
- Routes
- Oral
- Manufacturers / labelers
- 17
- Strengths listed
- 1 g/1 · 900 mg/1
- Brand names in FDA listings
- Omega-3-Acid Ethyl Ester
Official drug information
Source coverage for Omega-3 Acid Ethyl Esters (Usp):
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 484348
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
- ANDA 091028
- Sponsor
- RENOVA PHARMS
- Original approval
- 2014-04-07
- Listings
- 2
- Application
- ANDA 203893
- Sponsor
- ONESOURCE
- Original approval
- 2017-09-19
- Listings
- 3
- Application
- ANDA 207420
- Sponsor
- ASCENT PHARMS INC
- Original approval
- 2019-02-25
- Listings
- 8
- Application
- ANDA 211355
- Sponsor
- SOFGEN PHARMS
- Original approval
- 2019-07-10
- Listings
- 1
- Application
- ANDA 206455
- Sponsor
- CHARTWELL
- Original approval
- 2019-08-07
- Listings
- 2
- Application
- ANDA 210093
- Sponsor
- PURACAP PHARM LLC
- Original approval
- 2020-06-15
- Listings
- 7
- Application
- ANDA 212504
- Sponsor
- PHARMOBEDIENT
- Original approval
- 2020-08-19
- Listings
- 1
- Application
- ANDA 215458
- Sponsor
- MANKIND PHARMA
- Original approval
- 2021-11-15
- Listings
- 2
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 091028 | RENOVA PHARMS | 2014-04-07 | 2 |
| ANDA 203893 | ONESOURCE | 2017-09-19 | 3 |
| ANDA 207420 | ASCENT PHARMS INC | 2019-02-25 | 8 |
| ANDA 211355 | SOFGEN PHARMS | 2019-07-10 | 1 |
| ANDA 206455 | CHARTWELL | 2019-08-07 | 2 |
| ANDA 210093 | PURACAP PHARM LLC | 2020-06-15 | 7 |
| ANDA 212504 | PHARMOBEDIENT | 2020-08-19 | 1 |
| ANDA 215458 | MANKIND PHARMA | 2021-11-15 | 2 |
Official labeling on DailyMed
- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [REMEDYREPACK INC.] · version 1 · 2026-09-07
- OMEGA-3-ACID ETHYL ESTERS CAPSULE [STRIDES PHARMA SCIENCE LIMITED] · version 8 · 2026-09-03
- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] · version 5 · 2026-06-08
- OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [CAMBER PHARMACEUTICALS, INC.] · version 4 · 2026-05-11
- OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [XLCARE PHARMACEUTICALS, INC.] · version 4 · 2026-05-11
- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [REMEDYREPACK INC.] · version 9 · 2026-04-28
- OMEGA-3-ACID ETHYL ESTERS CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 3 · 2026-04-08
- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [LIFESTAR PHARMA LLC] · version 11 · 2026-02-16
- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS] · version 3 · 2026-01-21
- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS] · version 3 · 2026-01-21
- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [CHARTWELL RX, LLC] · version 5 · 2025-12-23
- OMEGA-3-ACID ETHYL ESTERS CAPSULE [AMERICAN HEALTH PACKAGING] · version 2 · 2025-04-30
Showing the 12 most recent of 25 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.