icosapent ethyl 500 MG Oral Capsule
- RxCUI
- 1811180
- RxNorm name
- icosapent ethyl 500 MG Oral Capsule
- Display name
- Icosapent ethyl (Oral Pill)
- Full name
- icosapent ethyl 500 MG Oral Capsule
- Term type
- SCD
- Status
- Active
- Strength
- 500 mg
- Dose form
- Cap
- Route
- Oral Pill
- Updated
- 2026-10-24 12:48:42
RxNorm Status History#
- Status
- Active
- Source
- RXNORM
- Current
- YES
- Release start
- 112016
- Active start
- 112016
- Multiple ingredient
- NO
- Branded
- NO
Ingredients And Strength#
| Ingredient | Strength | Base | Basis of strength |
|---|---|---|---|
| icosapent ethyl | 500 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#
| Code type | Values | Count | Category |
|---|---|---|---|
| PRESCRIBABLE | Y | 1 | ATTRIBUTES |
| RXNAV_STR | icosapent ethyl 500 MG Oral Capsule | 1 | NAMES |
| RxNorm Name | icosapent ethyl 500 MG Oral Capsule | 1 | NAMES |
| RxNorm Synonym | icosapent ethyl 0.5 GM Oral Capsule | 1 | NAMES |
| TTY | SCD | 1 | ATTRIBUTES |
| SPL_SET_ID | 10 linked values
| 10 | CODES |
| RxCUI | 1811180 | 1 | CODES |
| MMSL_CODE | 2 | CODES |
FDA NDC Products And Packages#
| Package NDC | Product NDC | Name | Labeler | Application |
|---|---|---|---|---|
| 0054-0621-27 | 0054-0621 | Icosapent Ethyl Icosapent Ethyl | Hikma Pharmaceuticals USA Inc. | ANDA209457 |
| 0480-0126-49 | 0480-0126 | Icosapent Ethyl Icosapent Ethyl | Teva Pharmaceuticals, Inc. | ANDA209525 |
| 31722-298-24 | 31722-298 | ICOSAPENT ETHYL Icosapent ethyl | Camber Pharmaceuticals, Inc. | ANDA216811 |
| 35916-1738-1 | 35916-1738 | icosapent ethyl icosapent ethyl | Softgel Healthcare Private Limited | ANDA217656 |
| 42806-559-24 | 42806-559 | ICOSAPENT ETHYL icosapent ethyl | EPIC PHARMA, LLC | ANDA217919 |
| 43598-746-72 | 43598-746 | Icosapent Ethyl Icosapent Ethyl | Dr. Reddy's Laboratories, Inc. | ANDA209499 |
| 69238-2597-7 | 69238-2597 | Icosapent ethyl Icosapent ethyl | Amneal Pharmaceuticals LLC | ANDA217844 |
| 70710-1738-4 | 70710-1738 | icosapent ethyl icosapent ethyl | Zydus Pharmaceuticals USA Inc. | ANDA217656 |
| 72865-289-24 | 72865-289 | ICOSAPENT ETHYL Icosapent ethyl | XLCare Pharmaceuticals, Inc. | ANDA216811 |
Drugs@FDA Applications#
| Application | NDC | Name | Marketing category | Labeler |
|---|---|---|---|---|
| ANDA209457 | 0054-0621 | Icosapent Ethyl Icosapent Ethyl | ANDA | Hikma Pharmaceuticals USA Inc. |
| ANDA209525 | 0480-0126 | Icosapent Ethyl Icosapent Ethyl | ANDA | Teva Pharmaceuticals, Inc. |
| ANDA216811 | 31722-298 | ICOSAPENT ETHYL Icosapent ethyl | ANDA | Camber Pharmaceuticals, Inc. |
| ANDA217656 | 35916-1738 | icosapent ethyl icosapent ethyl | ANDA | Softgel Healthcare Private Limited |
| ANDA217919 | 42806-559 | ICOSAPENT ETHYL icosapent ethyl | ANDA | EPIC PHARMA, LLC |
| ANDA209499 | 43598-746 | Icosapent Ethyl Icosapent Ethyl | ANDA | Dr. Reddy's Laboratories, Inc. |
| ANDA217844 | 69238-2597 | Icosapent ethyl Icosapent ethyl | ANDA | Amneal Pharmaceuticals LLC |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Icosapent Ethyl | ICOSAPENT ETHYL | Dr. Reddy's Laboratories, Inc. | cdcee03e-5df1-a8fc-7490-dfdc624ce6d6 | 2026-07-22 | Warnings, Adverse reactions | 43598-746-72 43598-746 43598074672 1811180 |
| Icosapent Ethyl | ICOSAPENT ETHYL | Hikma Pharmaceuticals USA Inc. | e3d38d1d-fbe7-413d-849a-675e7dfa9b0a | 2026-07-09 | Warnings, Adverse reactions | 0054-0621-27 0054-0621 00054062127 1811180 |
| icosapent ethyl | ICOSAPENT ETHYL | Softgel Healthcare Private Limited | 6f5838cd-4d17-401d-8e2a-652d0e73c1e9 | 2026-07-09 | 35916-1738-1 35916-1738 35916173801 1811180 | |
| icosapent ethyl | ICOSAPENT ETHYL | Zydus Pharmaceuticals USA Inc. | 5910742b-c5e6-4029-9a19-97669e3808bc | 2026-07-07 | Warnings, Adverse reactions | 70710-1738-4 70710-1738 70710173804 1811180 |
| ICOSAPENT ETHYL | ICOSAPENT ETHYL | EPIC PHARMA, LLC | 6db749b9-c817-41cd-909f-dd60a90c9f73 | 2026-06-05 | Warnings, Adverse reactions | 42806-559-24 42806-559 42806055924 1811180 |
| ICOSAPENT ETHYL | ICOSAPENT ETHYL | Camber Pharmaceuticals, Inc. | 3e3498ab-f35e-4597-8556-89bf9fdd1406 | 2026-04-30 | Warnings, Adverse reactions | 31722-298-24 31722-298 31722029824 1811180 |
| ICOSAPENT ETHYL | ICOSAPENT ETHYL | XLCare Pharmaceuticals, Inc. | 019cc0ac-0c2f-426d-996a-6d932f954443 | 2026-04-30 | Warnings, Adverse reactions | 72865-289-24 72865-289 72865028924 1811180 |
| Vascepa | ICOSAPENT ETHYL | Amarin Pharma Inc. | 9c1a2828-1583-4414-ab22-a60480e8e508 | 2026-03-23 | Warnings, Adverse reactions | 1811180 |
| Icosapent ethyl | ICOSAPENT ETHYL | Amneal Pharmaceuticals LLC | fd2b5373-1ddd-46c0-a579-d5a4f289d79f | 2025-03-11 | Warnings, Adverse reactions | 69238-2597-7 69238-2597 69238259707 1811180 |
| Icosapent Ethyl | ICOSAPENT ETHYL | Teva Pharmaceuticals, Inc. | de7049ae-d1d6-4267-a93b-dd5039c50c2c | 2021-08-27 | Warnings, Adverse reactions | 0480-0126-49 0480-0126 00480012649 1811180 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 9c1a2828-1583-4414-ab22-a60480e8e508 | icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 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 |
| 6db749b9-c817-41cd-909f-dd60a90c9f73 | icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 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 |
| cdcee03e-5df1-a8fc-7490-dfdc624ce6d6 | icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 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 | 20230417 |
| e3d38d1d-fbe7-413d-849a-675e7dfa9b0a | icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 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 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 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 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 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 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 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 |
| 019cc0ac-0c2f-426d-996a-6d932f954443 | icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 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 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 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 |
| 6f5838cd-4d17-401d-8e2a-652d0e73c1e9 | icosapent ethyl 0.5 GM Oral Capsule [PSN] · icosapent ethyl 500 MG Oral Capsule [SCD] · icosapent ethyl 0.5 GM Oral Capsule [SY] | 3 | 1 | ICOSAPENT ETHYL capsules, for oral use | 20241025 |
Recently Linked DailyMed Labels#
| Set ID | Title | Manufacturer | Effective |
|---|---|---|---|
| cdcee03e-5df1-a8fc-7490-dfdc624ce6d6 | 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 |
| cdcee03e-5df1-a8fc-7490-dfdc624ce6d6 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 6f5838cd-4d17-401d-8e2a-652d0e73c1e9 | ICOSAPENT ETHYL capsules, for oral use | Softgel Healthcare Private Limited | 20241025 |
| 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 |
| cdcee03e-5df1-a8fc-7490-dfdc624ce6d6 | 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. | 20230417 |
| 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. | 20210827 |
| 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 |
| 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 | 500 MG |
| ATTRIBUTES | GENERAL_CARDINALITY | SINGLE |
| ATTRIBUTES | HUMAN_DRUG | US |
| ATTRIBUTES | RXNAV_HUMAN_DRUG | US |
| ATTRIBUTES | SCHEDULE | 0 |
| CODES | ANDA | ANDA209457 |
| CODES | ANDA | ANDA209499 |
| CODES | ANDA | ANDA209525 |
| CODES | ANDA | ANDA216811 |
| CODES | ANDA | ANDA217656 |
| CODES | ANDA | ANDA217844 |
| CODES | ANDA | ANDA217919 |
| CODES | VUID | 4036129 |
| NAMES | Prescribable Synonym | icosapent ethyl 0.5 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 |