Home NDC 60687-764 Icosapent Ethyl
Product NDC 60687-764
11-digit product format 606870764
Labeler code 60687
Product ID 60687-764_47a64acc-3806-d861-e063-6394a90a8d02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icosapent Ethyl
Dosage form CAPSULE
Route ORAL
Labeler American Health Packaging
Application ANDA209437
Marketing category ANDA
Marketing start 2024-02-21
Marketing end 2027-05-31
Substance ICOSAPENT ETHYL
Active strength 1 g/1
NDC exclude flag No
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209437-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209437-001 AB
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 A209437-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2021-06-30 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 A209437-001 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Icosapent Ethyl Active Ingredients# Ingredient, Strength table Ingredient Strength ICOSAPENT ETHYL 1 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1304979 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 60687-764-11 Icosapent Ethyl 1 in 1 BLISTER PACK CAPSULE 1 5 60687-764-21 Icosapent Ethyl 30 in 1 CARTON CAPSULE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-764 ICOSAPENT ETHYL CAPSULE [AMERICAN HEALTH PACKAGING] 3 Current NDC, 2 package rows 20240328_fd28217d-5817-43b0-8185-7c7ec6da83f3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60687-764-11 60687076411 1 in 1 BLISTER PACK Historical 60687-764-21 60687076421 30 BLISTER PACK in 1 CARTON (60687-764-21) / 1 CAPSULE in 1 BLISTER PACK (60687-764-11) 30 blister pack 2024-02-21 2027-05-31 No No Historical