Medicine
Omega-3-Acid Ethyl Ester 900 mg capsule
Omega-3-Acid Ethyl Ester 900 mg capsule is a prescription medicine containing Omega-3 ethyl esters for oral use, marketed by Bionpharma, 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 25°C (77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Omega-3 ethyl esters
- Brand
- Omega-3-Acid Ethyl Ester
- Strength
- 900 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules, 120 capsules
- Marketing authorisation holder
- Bionpharma
- Manufacturers
- BionpharmaBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°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
- 15 January 2017
- Identifiers
- RxCUI 577208DailyMed set ID 09ce03c0-1c22-4c60-a532-f781949f3172, 91ef2e89-e816-4494-9558-2f647b7452f8NDC 63629-2448, 69452-175Application ANDA206455
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 capsule, liquid filled in 1 bottle | 69452-175-17 | Bionpharma | 15 January 2017 |
| 120 capsule, liquid filled in 1 bottle | 69452-175-22 | Bionpharma | 15 January 2017 |
| 120 capsule, liquid filled in 1 bottle | 63629-2448-1 | Bryant Ranch Prepack | 10 November 2021 |
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
Alternatives
Other makers and brands of Omega-3 ethyl esters 900 mg capsule.
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-Acid Ethyl Ester 900 mg 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.