Home NDC 35916-1738 icosapent ethyl
Product NDC 35916-1738
11-digit product format 359161738
Labeler code 35916
Product ID 35916-1738_51ab40c9-9b15-4fa3-a355-6ac5d36552ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name icosapent ethyl
Dosage form CAPSULE
Route ORAL
Labeler Softgel Healthcare Private Limited
Application ANDA217656
Marketing category ANDA
Marketing start 2025-03-01
Substance ICOSAPENT ETHYL
Active strength .5 g/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217656-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-04-20 A217656-002 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-04-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A217656-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-04-20 a50c72e98297…2026-08-01 22:54:32 2026-06 A217656-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2023-04-20 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A217656-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A217656-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base icosapent ethyl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ICOSAPENT ETHYL .5 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6GC8A4PAYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1304979 Internal RxNorm lookup 1811180 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35916-1738-1 icosapent ethyl 240 in 1 BOTTLE CAPSULE 240 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35916-1738 ICOSAPENT ETHYL CAPSULE [SOFTGEL HEALTHCARE PRIVATE LIMITED] 1 Current NDC, 1 package rows 20250302_6f5838cd-4d17-401d-8e2a-652d0e73c1e9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 35916-1738-1 35916173801 240 CAPSULE in 1 BOTTLE (35916-1738-1) 240 capsule 2025-03-01 No No Current