Home NDC 63629-9312 Icosapent
Product NDC 63629-9312
11-digit product format 636299312
Labeler code 63629
Product ID 63629-9312_8988eb81-87de-4d83-8d5a-f9e0d2863618
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icosapent Ethyl
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA209499
Marketing category ANDA
Marketing start 2021-06-21
Substance ICOSAPENT ETHYL
Active strength 1000 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 A209499-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 A209499-002 ICOSAPENT ETHYL ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08
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 A209499-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2020-08-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A209499-002 ICOSAPENT ETHYL 500MG CAPSULE / ORAL AB 2023-03-08 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 A209499-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A209499-002 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Icosapent
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ICOSAPENT ETHYL 1000 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 · 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 63629-9312-1 Icosapent 120 in 1 BOTTLE CAPSULE 120 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-9312 ICOSAPENT (ICOSAPENT ETHYL) CAPSULE [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 1 package rows 20240116_cc28828d-beab-45cc-a3b6-151c5fee3924.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 63629-9312-1 63629931201 120 CAPSULE in 1 BOTTLE (63629-9312-1) 120 capsule 2022-07-06 0000-00-00 No No Current