Home NDC 0480-0126 Icosapent Ethyl
Product NDC 0480-0126
11-digit product format 004800126
Labeler code 0480
Product ID 0480-0126_0d2afdd4-3333-47dc-9653-0b63e478b36d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icosapent Ethyl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA209525
Marketing category ANDA
Marketing start 2022-09-09
Substance ICOSAPENT ETHYL
Active strength 500 mg/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 A209525-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 A209525-002 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11
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 A209525-001 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2020-09-11 a50c72e98297…2026-08-01 22:54:32 2026-06 A209525-002 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-09-11 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 A209525-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A209525-002 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 · 1 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 500 mg/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 0480-0126-49 Icosapent Ethyl 240 in 1 BOTTLE CAPSULE, LIQUID FILLED 240 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-0126 ICOSAPENT ETHYL CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250112_de7049ae-d1d6-4267-a93b-dd5039c50c2c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0480-0126-49 00480012649 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0126-49) 2022-09-09 0000-00-00 No No Current