icosapent ethyl 1000 MG Oral Capsule
- RxCUI
- 1304979
- RxNorm name
- icosapent ethyl 1000 MG Oral Capsule
- Display name
- Icosapent ethyl (Oral Pill)
- Full name
- icosapent ethyl 1000 MG Oral Capsule
- Term type
- SCD
- Status
- Active
- Strength
- 1,000 mg
- Dose form
- Cap
- Route
- Oral Pill
- Updated
- 2026-07-21 06:57:13
RxNorm Status History#
- Status
- Active
- Source
- RXNORM
- Current
- YES
- Release start
- 092012
- Active start
- 092012
- Multiple ingredient
- NO
- Branded
- NO
Ingredients And Strength#
| Ingredient | Strength | Base | Basis of strength |
|---|---|---|---|
| icosapent ethyl | 1000 MG / 1 EACH | icosapent ethyl | icosapent ethyl |
Dose Form Concepts#
| Dose form | RxCUI |
|---|---|
| Oral Capsule | 316965 |
Derived Ingredient Concepts#
| Ingredient | RxCUI |
|---|---|
| icosapent ethyl | 1304974 |
Source Vocabulary Codes#
FDA NDC Products And Packages#
| Package NDC | Product NDC | Name | Labeler | Application |
|---|---|---|---|---|
| 0054-0508-23 | 0054-0508 | Icosapent Ethyl Icosapent Ethyl | Hikma Pharmaceuticals USA Inc. | ANDA209457 |
| 0480-0127-89 | 0480-0127 | Icosapent Ethyl Icosapent Ethyl | Teva Pharmaceuticals, Inc. | ANDA209525 |
| 13668-761-12 | 13668-761 | Icosapent Ethyl Icosapent Ethyl Capsules | Torrent Pharmaceuticals Limited | ANDA218994 |
| 16714-636-01 | 16714-636 | ICOSAPENT ETHYL Icosapent ethyl | Northstar Rx LLC | ANDA216811 |
| 31722-299-12 | 31722-299 | ICOSAPENT ETHYL Icosapent ethyl | Camber Pharmaceuticals, Inc. | ANDA216811 |
| 35916-1592-1 | 35916-1592 | icosapent ethyl icosapent ethyl | Softgel Healthcare Private Limited | ANDA217656 |
| 42291-046-12 | 42291-046 | Icosapent Ethyl Icosapent Ethyl | AvKARE | ANDA209525 |
| 42806-560-12 | 42806-560 | ICOSAPENT ETHYL icosapent ethyl | EPIC PHARMA, LLC | ANDA217919 |
| 43598-267-04 | 43598-267 | Icosapent Icosapent Ethyl | Dr. Reddy's Laboratories, Inc. | ANDA209499 |
| 60429-005-12 | 60429-005 | Icosapent Ethyl Icosapent Ethyl | Golden State Medical Supply, Inc. | ANDA209437 |
| 60505-4033-1 | 60505-4033 | Icosapent Ethyl Icosapent Ethyl | Apotex Corp | ANDA209437 |
| 60687-764-21 | 60687-764 | Icosapent Ethyl Icosapent Ethyl | American Health Packaging | ANDA209437 |
| 63629-9311-1 | 63629-9311 | Icosapent Ethyl Icosapent Ethyl | Bryant Ranch Prepack | ANDA209457 |
| 63629-9312-1 | 63629-9312 | Icosapent Icosapent Ethyl | Bryant Ranch Prepack | ANDA209499 |
| 64380-285-01 | 64380-285 | Icosapent ethyl Icosapent ethyl | Strides Pharma Science Limited | ANDA217844 |
| 67184-0582-1 | 67184-0582 | Icosapent Ethyl Icosapent Ethyl | Qilu Pharmaceutical Co., Ltd. | ANDA218899 |
| 69238-2598-8 | 69238-2598 | Icosapent ethyl Icosapent ethyl | Amneal Pharmaceuticals LLC | ANDA217844 |
| 69680-186-92 | 69680-186 | Icosapent Ethyl Icosapent Ethyl | Vitruvias Therapeutics, Inc. | ANDA219156 |
| 70710-1592-7 | 70710-1592 | icosapent ethyl icosapent ethyl | Zydus Pharmaceuticals USA Inc. | ANDA217656 |
| 71335-2842-1 | 71335-2842 | Icosapent Ethyl Icosapent Ethyl | Bryant Ranch Prepack | ANDA209457 |
| 71335-2989-1 | 71335-2989 | ICOSAPENT ETHYL Icosapent ethyl | Bryant Ranch Prepack | ANDA216811 |
| 71335-2989-2 | 71335-2989 | ICOSAPENT ETHYL Icosapent ethyl | Bryant Ranch Prepack | ANDA216811 |
| 71335-2989-3 | 71335-2989 | ICOSAPENT ETHYL Icosapent ethyl | Bryant Ranch Prepack | ANDA216811 |
| 71335-2989-4 | 71335-2989 | ICOSAPENT ETHYL Icosapent ethyl | Bryant Ranch Prepack | ANDA216811 |
| 71335-3072-1 | 71335-3072 | Icosapent Ethyl Icosapent Ethyl | Bryant Ranch Prepack | ANDA209457 |
| 71335-3072-2 | 71335-3072 | Icosapent Ethyl Icosapent Ethyl | Bryant Ranch Prepack | ANDA209457 |
| 71335-3072-3 | 71335-3072 | Icosapent Ethyl Icosapent Ethyl | Bryant Ranch Prepack | ANDA209457 |
| 71335-3072-4 | 71335-3072 | Icosapent Ethyl Icosapent Ethyl | Bryant Ranch Prepack | ANDA209457 |
| 72162-1000-2 | 72162-1000 | Icosapent Ethyl Icosapent Ethyl | Bryant Ranch Prepack | ANDA209457 |
| 72603-129-01 | 72603-129 | Icosapent Ethyl Icosapent Ethyl | Northstar Rx LLC | ANDA209457 |
| 72865-290-12 | 72865-290 | ICOSAPENT ETHYL Icosapent ethyl | XLCare Pharmaceuticals, Inc. | ANDA216811 |
Drugs@FDA Applications#
| Application | NDC | Name | Marketing category | Labeler |
|---|---|---|---|---|
| ANDA209457 | 0054-0508 | Icosapent Ethyl Icosapent Ethyl | ANDA | Hikma Pharmaceuticals USA Inc. |
| ANDA209525 | 0480-0127 | Icosapent Ethyl Icosapent Ethyl | ANDA | Teva Pharmaceuticals, Inc. |
| ANDA218994 | 13668-761 | Icosapent Ethyl Icosapent Ethyl Capsules | ANDA | Torrent Pharmaceuticals Limited |
| ANDA216811 | 16714-636 | ICOSAPENT ETHYL Icosapent ethyl | ANDA | Northstar Rx LLC |
| ANDA217656 | 35916-1592 | icosapent ethyl icosapent ethyl | ANDA | Softgel Healthcare Private Limited |
| ANDA217919 | 42806-560 | ICOSAPENT ETHYL icosapent ethyl | ANDA | EPIC PHARMA, LLC |
| ANDA209499 | 43598-267 | Icosapent Icosapent Ethyl | ANDA | Dr. Reddy's Laboratories, Inc. |
| ANDA209437 | 60429-005 | Icosapent Ethyl Icosapent Ethyl | ANDA | Golden State Medical Supply, Inc. |
| ANDA217844 | 64380-285 | Icosapent ethyl Icosapent ethyl | ANDA | Strides Pharma Science Limited |
| ANDA218899 | 67184-0582 | Icosapent Ethyl Icosapent Ethyl | ANDA | Qilu Pharmaceutical Co., Ltd. |
| ANDA219156 | 69680-186 | Icosapent Ethyl Icosapent Ethyl | ANDA | Vitruvias Therapeutics, Inc. |
UNII Substances#
No records found.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| cc28828d-beab-45cc-a3b6-151c5fee3924 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 102 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20240115 |
| f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 102 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20240115 |
| 582638e5-9881-409d-a455-041b5ba6892a | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 100 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20251021 |
| 0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 100 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20241224 |
| 9c1a2828-1583-4414-ab22-a60480e8e508 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 21 | These highlights do not include all the information needed to use VASCEPA ® safely and effectively. See full prescribing information for VASCEPA. VASCEPA ® (icosapent ethyl) capsules, for oral use Initial U.S. Approval: 2012 | 20260323 |
| d245ddab-d81b-44bd-90d7-0e4d446d9bf5 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 7 | These highlights do not include all the information needed to use VASCEPA ® safely and effectively. See full prescribing information for VASCEPA. VASCEPA ® (icosapent ethyl) capsules, for oral use Initial U.S. Approval: 2012 | 20260407 |
| 886aa8d8-b293-258f-b16d-be40418787a8 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 6 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20260331 |
| fd28217d-5817-43b0-8185-7c7ec6da83f3 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 5 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20260105 |
| 6db749b9-c817-41cd-909f-dd60a90c9f73 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 4 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20260331 |
| e3d38d1d-fbe7-413d-849a-675e7dfa9b0a | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 4 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20230309 |
| 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 3 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20250311 |
| fd2b5373-1ddd-46c0-a579-d5a4f289d79f | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 3 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20250311 |
| 5910742b-c5e6-4029-9a19-97669e3808bc | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 3 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20250226 |
| 1aca884c-c464-900d-ac06-33aee7118df8 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 3 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20210628 |
| 019cc0ac-0c2f-426d-996a-6d932f954443 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 2 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20260430 |
| 3e3498ab-f35e-4597-8556-89bf9fdd1406 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 2 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20260430 |
| 0bc72bd8-1f33-b01c-e063-6394a90a77ea | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 2 | Icosapent Ethyl Capsules Rx Only These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. Initial U.S. Approval: 2012 | 20260113 |
| 45f8bb41-bdb1-4afc-83ec-9dc69720ee9c | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 2 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20231222 |
| 24105b33-bbb7-4349-a5d0-8fe4af7e4994 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 1 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20260422 |
| 07631e74-48e5-46ec-b8db-4b1bcf62d283 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 1 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20260209 |
| b4a1ca8a-2d22-4c54-9193-eab4e75ba7db | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 1 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20260204 |
| 20686acb-66c5-4d75-9684-7474436e8bef | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 1 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20251030 |
| 4c3e26d6-9297-42ad-94b4-04e394155b41 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 1 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20251021 |
| 3637187f-70bc-eb31-e063-6294a90ad3cb | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 1 | ICOSAPENT ETHYL CAPSULES. These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20250528 |
| b5b0b1ae-29ab-43a5-9e6d-24374d961399 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 1 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | 20250305 |
| 6f5838cd-4d17-401d-8e2a-652d0e73c1e9 | icosapent ethyl 1 GM Oral Capsule [PSN] · icosapent ethyl 1000 MG Oral Capsule [SCD] · icosapent ethyl 1 GM Oral Capsule [SY] | 3 | 1 | ICOSAPENT ETHYL capsules, for oral use | 20241025 |
Recently Linked DailyMed Labels#
| Set ID | Title | Manufacturer | Effective |
|---|---|---|---|
| cc28828d-beab-45cc-a3b6-151c5fee3924 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20260810 |
| f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20260810 |
| 45f8bb41-bdb1-4afc-83ec-9dc69720ee9c | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Northstar Rx LLC | 20260729 |
| 1aca884c-c464-900d-ac06-33aee7118df8 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Dr. Reddy's Laboratories, Inc. | 20260722 |
| 1aca884c-c464-900d-ac06-33aee7118df8 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Dr. Reddy's Laboratories, Inc. | 20260713 |
| e3d38d1d-fbe7-413d-849a-675e7dfa9b0a | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Hikma Pharmaceuticals USA Inc. | 20260709 |
| 6f5838cd-4d17-401d-8e2a-652d0e73c1e9 | ICOSAPENT ETHYL capsules, for oral use | Softgel Healthcare Private Limited | 20260709 |
| 5910742b-c5e6-4029-9a19-97669e3808bc | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Doppel Farmaceutici S.r.l. | Softgel Healthcare Private Limited | 20260707 |
| b6e361cc-c314-4402-9361-2d977788e93c | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20260618 |
| 6db749b9-c817-41cd-909f-dd60a90c9f73 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | EPIC PHARMA, LLC | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd | 20260605 |
| 30574162-0e84-4352-b7fa-42fc20115d68 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | EPIC PHARMA, LLC | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd | 20260605 |
| 3e3498ab-f35e-4597-8556-89bf9fdd1406 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Camber Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc | 20260430 |
| 019cc0ac-0c2f-426d-996a-6d932f954443 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | XLCare Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc | 20260430 |
| 24105b33-bbb7-4349-a5d0-8fe4af7e4994 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Torrent Pharmaceuticals Limited | 20260422 |
| 886aa8d8-b293-258f-b16d-be40418787a8 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Apotex Corp | Apotex Inc. | 20260331 |
| 6db749b9-c817-41cd-909f-dd60a90c9f73 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | EPIC PHARMA, LLC | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd | 20260331 |
| 07631e74-48e5-46ec-b8db-4b1bcf62d283 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20260209 |
| b4a1ca8a-2d22-4c54-9193-eab4e75ba7db | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20260204 |
| 0bc72bd8-1f33-b01c-e063-6394a90a77ea | Icosapent Ethyl Capsules Rx Only These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. Initial U.S. Approval: 2012 | AvKARE | 20260113 |
| fd28217d-5817-43b0-8185-7c7ec6da83f3 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | American Health Packaging | 20260105 |
| fd28217d-5817-43b0-8185-7c7ec6da83f3 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | American Health Packaging | 20251113 |
| 20686acb-66c5-4d75-9684-7474436e8bef | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd.(High-Tech Zone Site) | 20251030 |
| 582638e5-9881-409d-a455-041b5ba6892a | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20251021 |
| 4c3e26d6-9297-42ad-94b4-04e394155b41 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Vitruvias Therapeutics, Inc. | 20251021 |
| 3637187f-70bc-eb31-e063-6294a90ad3cb | ICOSAPENT ETHYL CAPSULES. These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Golden State Medical Supply, Inc. | 20250528 |
| fd2b5373-1ddd-46c0-a579-d5a4f289d79f | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Amneal Pharmaceuticals LLC | Strides Pharma Global Pte. Ltd. | Strides Pharma Science Limited | 20250311 |
| 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd. | 20250311 |
| b5b0b1ae-29ab-43a5-9e6d-24374d961399 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Northstar Rx LLC | Ascent Pharmaceuticals, Inc | 20250305 |
| 5910742b-c5e6-4029-9a19-97669e3808bc | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Doppel Farmaceutici S.r.l. | Softgel Healthcare Private Limited | 20250226 |
| 0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20241224 |
| 6f5838cd-4d17-401d-8e2a-652d0e73c1e9 | ICOSAPENT ETHYL capsules, for oral use | Softgel Healthcare Private Limited | 20241025 |
| 07a8174b-f0ed-c277-e063-6394a90a9eb1 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Softgel Healthcare Private Limited | 20240606 |
| 5c84fe3c-68d3-4906-a133-132b8c5e9eb0 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Ascent Pharmaceuticals, Inc | 20240304 |
| 0fb2eb8a-e308-0177-e063-6294a90a7418 | ICOSAPENT ETHYL capsules, for oral use These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. Initial U.S. Approval: 2012 | AvKARE | 20240124 |
| cc28828d-beab-45cc-a3b6-151c5fee3924 | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20240115 |
| f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Bryant Ranch Prepack | 20240115 |
| 45f8bb41-bdb1-4afc-83ec-9dc69720ee9c | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Northstar Rx LLC | 20231222 |
| e3d38d1d-fbe7-413d-849a-675e7dfa9b0a | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Hikma Pharmaceuticals USA Inc. | 20230309 |
| de7049ae-d1d6-4267-a93b-dd5039c50c2c | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Teva Pharmaceuticals, Inc. | 20210831 |
| de7049ae-d1d6-4267-a93b-dd5039c50c2c | These highlights do not include all the information needed to use ICOSAPENT ETHYL CAPSULES safely and effectively. See full prescribing information for ICOSAPENT ETHYL CAPSULES. ICOSAPENT ETHYL capsules, for oral use Initial U.S. Approval: 2012 | Teva Pharmaceuticals, Inc. | 20210801 |
Drug Classes#
| Source | Class ID | Class | Type | Relationship | Drug concept |
|---|---|---|---|---|---|
| MEDRT | D015118 | Eicosapentaenoic Acid | CHEM | has_ingredient | icosapent ethyl |
Properties#
| Category | Property | Value |
|---|---|---|
| ATTRIBUTES | AVAILABLE_STRENGTH | 1000 MG |
| ATTRIBUTES | GENERAL_CARDINALITY | SINGLE |
| ATTRIBUTES | HUMAN_DRUG | US |
| ATTRIBUTES | RXNAV_HUMAN_DRUG | US |
| ATTRIBUTES | SCHEDULE | 0 |
| CODES | ANDA | ANDA209437 |
| CODES | ANDA | ANDA209457 |
| CODES | ANDA | ANDA209499 |
| CODES | ANDA | ANDA209525 |
| CODES | ANDA | ANDA216811 |
| CODES | ANDA | ANDA217656 |
| CODES | ANDA | ANDA217844 |
| CODES | ANDA | ANDA217919 |
| CODES | ANDA | ANDA218899 |
| CODES | ANDA | ANDA218994 |
| CODES | ANDA | ANDA219156 |
| CODES | VUID | 4032045 |
| NAMES | Prescribable Synonym | icosapent ethyl 1 GM Oral Capsule |
| SOURCES | Source | Gold Standard Alchemy |
| SOURCES | Source | Metathesaurus FDA Structured Product Labels |
| SOURCES | Source | Micromedex RED BOOK |
| SOURCES | Source | Multum MediSource Lexicon |
| SOURCES | Source | National Drug Data File Plus Source Vocabulary |
| SOURCES | Source | Veterans Health Administration National Drug File |