Icosapent Ethyl Capsules, For Oral Use

SPL v1

SPL

SPL Set ID 6f5838cd-4d17-401d-8e2a-652d0e73c1e9

Route

ORAL

Published

Effective Date 2024-10-25

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Icosapent (0.5 g)

Inactive Ingredients

.alpha.-tocopherol Gelatin Glycerin Water Titanium Dioxide Shellac

Identifiers & Packaging

Pill Appearance

Imprint: 1592 Shape: oval Color: white Size: 14 mm Size: 24 mm Score: 1

Marketing Status

ANDA Active Since 2025-03-01

Description

NDC 35916-1738-1 Icosapent Ethyl Capsules 0.5 gram 240 capsules Rx only NDC 35916-1592-1 Icosapent Ethyl Capsules 1 gram 240 capsules Rx only

Medication Information

Description

NDC 35916-1738-1 Icosapent Ethyl Capsules 0.5 gram 240 capsules Rx only NDC 35916-1592-1 Icosapent Ethyl Capsules 1 gram 240 capsules Rx only

Package Label.principal Display Panel

NDC 35916-1738-1

Icosapent Ethyl Capsules

0.5 gram

240 capsules

Rx only

NDC 35916-1592-1

Icosapent Ethyl Capsules

1 gram

240 capsules

Rx only

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 35916-1738-1

Icosapent Ethyl Capsules

0.5 gram

240 capsules

Rx only

NDC 35916-1592-1

Icosapent Ethyl Capsules

1 gram

240 capsules

Rx only

Advanced Ingredient Data

[{"name": "ICOSAPENT", "unii": "AAN7QOV9EA", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ICOSAPENT", "unii": "AAN7QOV9EA", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 35916-1738-1 Icosapent Ethyl Capsules 0.5 gram 240 capsules Rx only NDC 35916-1592-1 Icosapent Ethyl Capsules 1 gram 240 capsules Rx only"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:45:56.429517 · Updated: 2026-03-14T22:23:37.577322