Medicine
Icosapent ethyl 0.5 g capsule
Icosapent ethyl 0.5 g capsule is a generic prescription medicine for oral use, made by 9 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 to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Icosapent ethyl
- Brand
- Sold under the generic name
- Strength
- 0.5 g
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 240 capsules and 6 more
- Manufacturers
- Camber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaSoftgel HealthcareIndiaZydus LifesciencesIndiaAmneal PharmaceuticalsEpic PharmaHikma PharmaceuticalsTeva PharmaceuticalsXLCare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 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 1811180, 1304979DailyMed set ID cdcee03e-5df1-a8fc-7490-dfdc624ce6d6, 019cc0ac-0c2f-426d-996a-6d932f954443, 6f5838cd-4d17-401d-8e2a-652d0e73c1e9 +6NDC 43598-746, 72865-289, 35916-1738 +6Application ANDA209499, ANDA216811, ANDA217656 +4
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 |
|---|---|---|---|
| 240 capsule in 1 bottle | 31722-298-24 | Camber PharmaceuticalsIndia | 16 February 2024 |
| 240 capsule in 1 bottle | 43598-746-72 | Dr. Reddy's LaboratoriesIndia | 17 April 2023 |
| 240 capsule in 1 bottle | 35916-1738-1 | Softgel HealthcareIndia | 1 March 2025 |
| 240 capsule in 1 bottle | 70710-1738-4 | Zydus LifesciencesIndia | 4 August 2023 |
| 240 capsule in 1 bottle | 69238-2597-7 | Amneal Pharmaceuticals | 1 November 2023 |
| 240 capsule, liquid filled in 1 bottle | 42806-559-24 | Epic Pharma | 22 December 2023 |
| 240 capsule in 1 bottle | 0054-0621-27 | Hikma Pharmaceuticals | 9 March 2023 |
| 240 capsule, liquid filled in 1 bottle | 0480-0126-49 | Teva Pharmaceuticals | 9 September 2022 |
| 240 capsule in 1 bottle | 72865-289-24 | XLCare Pharmaceuticals | 16 February 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.
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 0.5 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.