Medicine
Omega-3 ethyl esters 1 g capsule
Omega-3 ethyl esters 1 g capsule is a generic prescription medicine for oral use, made by 12 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store at 20°C to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Omega-3 ethyl esters
- Brand
- Sold under the generic name
- Strength
- 1 g
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 500 capsules, 120 capsules, 1440 capsules and 26 more
- Manufacturers
- Camber PharmaceuticalsIndiaLifestar PharmaIndiaBryant Ranch PrepackA-S Medication SolutionsRemedyrepackKD PharmaXLCare PharmaceuticalsBlu PharmaceuticalsEpic PharmaGolden State Medical Supply
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20°C to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 April 2014
- Identifiers
- RxCUI 577208DailyMed set ID c8dc6c4a-ed19-4727-ba5a-35075f1ddddf, 730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa, b11807f8-4301-4f91-8a7a-53226f945c49 +17NDC 71335-2024, 50090-5800, 50090-6822 +17Application ANDA210093, ANDA207420, ANDA212504 +2
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 capsule, liquid filled in 1 bottle | 31722-936-05 | Camber PharmaceuticalsIndia | 25 February 2019 |
| 120 capsule, liquid filled in 1 bottle | 31722-936-12 | Camber PharmaceuticalsIndia | 25 February 2019 |
| 120 capsule, liquid filled in 1 bottle | 70756-423-22 | Lifestar PharmaIndia | 16 November 2021 |
| 120 capsule in 1 bottle, plastic | 72998-850-12 | KD Pharma | 1 May 2021 |
| 120 capsule in 1 bottle, plastic | 72998-851-12 | KD Pharma | 1 February 2024 |
| 120 capsule, liquid filled in 1 bottle | 24658-350-12 | Blu Pharmaceuticals | 22 August 2023 |
| 120 capsule, liquid filled in 1 bottle | 42806-552-12 | Epic Pharma | 2 July 2020 |
| 500 capsule, liquid filled in 1 bottle | 72865-139-05 | XLCare Pharmaceuticals | 17 February 2020 |
| 120 capsule, liquid filled in 1 bottle | 72865-139-12 | XLCare Pharmaceuticals | 17 February 2020 |
| 120 capsule, liquid filled in 1 bottle | 50090-5799-0 | A-S Medication Solutions | 14 October 2021 |
| 1440 capsule, liquid filled in 1 bottle | 50090-5800-2 | A-S Medication Solutions | 25 January 2022 |
| 120 capsule, liquid filled in 1 bottle | 50090-6691-0 | A-S Medication Solutions | 18 September 2023 |
| 120 capsule, liquid filled in 1 bottle | 50090-6692-0 | A-S Medication Solutions | 18 September 2023 |
| 120 capsule, liquid filled in 1 bottle | 50090-6822-0 | A-S Medication Solutions | 4 January 2024 |
| 120 capsule, liquid filled in 1 bottle | 63629-1918-1 | Bryant Ranch Prepack | 25 February 2019 |
| 90 capsule, liquid filled in 1 bottle | 71335-2024-1 | Bryant Ranch Prepack | 10 January 2022 |
| 28 capsule, liquid filled in 1 bottle | 71335-2024-2 | Bryant Ranch Prepack | 10 January 2022 |
| 60 capsule, liquid filled in 1 bottle | 71335-2024-3 | Bryant Ranch Prepack | 10 January 2022 |
| 120 capsule, liquid filled in 1 bottle | 71335-2024-4 | Bryant Ranch Prepack | 10 January 2022 |
| 100 capsule, liquid filled in 1 bottle | 71335-2024-5 | Bryant Ranch Prepack | 10 January 2022 |
| 30 capsule, liquid filled in 1 bottle | 71335-2024-6 | Bryant Ranch Prepack | 10 January 2022 |
| 120 capsule, liquid filled in 1 bottle | 72162-1310-2 | Bryant Ranch Prepack | 6 October 2023 |
| 180 capsule, liquid filled in 1 bottle, plastic | 70518-3040-0 | Remedyrepack | 4 March 2021 |
| 50 pouch in 1 box / 1 capsule, liquid filled in 1 pouch | 70518-3040-1 | Remedyrepack | 25 April 2026 |
| 90 capsule, liquid filled in 1 bottle, plastic | 70518-3040-3 | Remedyrepack | 13 October 2026 |
| 180 capsule, liquid filled in 1 bottle, plastic | 70518-4744-0 | Remedyrepack | 2 September 2026 |
| 120 capsule in 1 bottle, plastic | 51407-763-12 | Golden State Medical Supply | 19 December 2023 |
| 50 blister pack in 1 carton / 1 capsule, liquid filled in 1 blister pack | 0904-7495-06 | Major Pharmaceuticals | 13 December 2024 |
| 30 capsule, liquid filled in 1 blister pack | 0615-8550-39 | Vangard Labs | 15 October 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 10 November 2004 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Omega-3 ethyl esters
Clinical summary
Omega-3 ethyl esters is an omega-3 fatty acid indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia. MedsAcross supplies Omega-3 ethyl esters for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Omega-3 ethyl estersFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- omega-3-acid ethyl esters prescribing information (Strides Pharma) · U.S. National Library of Medicine, DailyMed
Need Omega-3 ethyl esters 1 g capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.