Medicine
Icosapent ethyl 1 g capsule
Icosapent ethyl 1 g capsule is a generic prescription medicine for oral use, made by 17 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
Store at 20°C to 25° C (68°F to 77°F), excursions permitted from 15°C to 30° C…
Key facts
- Active ingredient (INN)
- Icosapent ethyl
- Brand
- Sold under the generic name
- Strength
- 1 g
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 120 capsules, 30 capsules, 60 capsules and 31 more
- Manufacturers
- Aurobindo PharmaIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaSoftgel HealthcareIndiaZydus LifesciencesIndiaBryant Ranch PrepackEpic PharmaNorthStar RxAmerican Health PackagingAmneal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25° C (68°F to 77°F), excursions permitted from 15°C to 30° C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AX Cholesterol and lipid-lowering medicines, subgroup C10A, subgroup C10AX
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 November 2020
- Identifiers
- RxCUI 1304979, 1811180DailyMed set ID 3637187f-70bc-eb31-e063-6294a90ad3cb, 886aa8d8-b293-258f-b16d-be40418787a8, fd28217d-5817-43b0-8185-7c7ec6da83f3 +22NDC 60429-005, 60505-4033, 60687-764 +22Application ANDA209437, ANDA217844, ANDA219156 +8
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 |
|---|---|---|---|
| 120 capsule in 1 bottle | 59651-812-08 | Aurobindo PharmaIndia | 24 June 2026 |
| 120 capsule in 1 bottle | 31722-299-12 | Camber PharmaceuticalsIndia | 16 February 2024 |
| 120 capsule in 1 bottle | 43598-267-04 | Dr. Reddy's LaboratoriesIndia | 21 June 2021 |
| 120 capsule in 1 bottle | 35916-1592-1 | Softgel HealthcareIndia | 1 March 2025 |
| 120 capsule in 1 bottle | 70710-1592-7 | Zydus LifesciencesIndia | 4 August 2023 |
| 120 capsule, liquid filled in 1 bottle | 42806-560-12 | Epic Pharma | 22 December 2023 |
| 120 capsule, liquid filled in 1 bottle | 42806-576-12 | Epic Pharma | 27 May 2026 |
| 120 capsule in 1 bottle | 69238-2598-8 | Amneal Pharmaceuticals | 1 November 2023 |
| 120 capsule in 1 bottle | 60505-4033-1 | Apotex | 16 December 2021 |
| 120 capsule in 1 bottle | 0054-0508-23 | Hikma Pharmaceuticals | 4 November 2020 |
| 120 capsule in 1 bottle | 67184-0582-1 | Qilu Pharmaceutical | 1 January 2025 |
| 120 capsule, liquid filled in 1 bottle | 0480-0127-89 | Teva Pharmaceuticals | 15 December 2022 |
| 120 capsule in 1 bottle | 69680-186-92 | Vitruvias Therapeutics | 20 October 2025 |
| 120 capsule in 1 bottle | 72865-290-12 | XLCare Pharmaceuticals | 16 February 2024 |
| 120 capsule in 1 bottle | 63629-9311-1 | Bryant Ranch Prepack | 10 August 2026 |
| 120 capsule in 1 bottle | 63629-9312-1 | Bryant Ranch Prepack | 10 August 2026 |
| 120 capsule in 1 bottle | 71335-2842-1 | Bryant Ranch Prepack | 21 October 2025 |
| 30 capsule in 1 bottle | 71335-2989-1 | Bryant Ranch Prepack | 4 February 2026 |
| 60 capsule in 1 bottle | 71335-2989-2 | Bryant Ranch Prepack | 4 February 2026 |
| 120 capsule in 1 bottle | 71335-2989-3 | Bryant Ranch Prepack | 4 February 2026 |
| 90 capsule in 1 bottle | 71335-2989-4 | Bryant Ranch Prepack | 4 February 2026 |
| 30 capsule in 1 bottle | 71335-3072-1 | Bryant Ranch Prepack | 9 February 2026 |
| 60 capsule in 1 bottle | 71335-3072-2 | Bryant Ranch Prepack | 9 February 2026 |
| 120 capsule in 1 bottle | 71335-3072-3 | Bryant Ranch Prepack | 9 February 2026 |
| 90 capsule in 1 bottle | 71335-3072-4 | Bryant Ranch Prepack | 9 February 2026 |
| 30 capsule, liquid filled in 1 bottle | 71335-3148-1 | Bryant Ranch Prepack | 18 June 2026 |
| 60 capsule, liquid filled in 1 bottle | 71335-3148-2 | Bryant Ranch Prepack | 18 June 2026 |
| 120 capsule, liquid filled in 1 bottle | 71335-3148-3 | Bryant Ranch Prepack | 18 June 2026 |
| 90 capsule, liquid filled in 1 bottle | 71335-3148-4 | Bryant Ranch Prepack | 18 June 2026 |
| 120 capsule in 1 bottle | 72162-1000-2 | Bryant Ranch Prepack | 24 December 2024 |
| 120 capsule in 1 bottle | 16714-636-01 | Northstar Rx | 1 July 2025 |
| 120 capsule in 1 bottle | 72603-129-01 | Northstar Rx | 31 January 2022 |
| 30 blister pack in 1 carton / 1 capsule in 1 blister pack | 60687-764-21 | American Health Packaging | 21 February 2024 |
| 120 capsule in 1 bottle | 60429-005-12 | Golden State Medical Supply | 31 March 2025 |
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.
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 Icosapent ethyl
Clinical summary
Icosapent ethyl is a prescription medicine indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Icosapent ethyl 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 Icosapent ethylFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Vascepa prescribing information (Amarin Pharma) · U.S. National Library of Medicine, DailyMed
- Vazkepa: European public assessment report (EPAR) · European Medicines Agency
Need Icosapent ethyl 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.