Home NDC 59651-812 Icosapent ethyl
Product NDC 59651-812
11-digit product format 596510812
Labeler code 59651
Product ID 59651-812_b30afc7a-bffb-4c71-974f-1d977156eb46
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icosapent ethyl
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA218949
Marketing category ANDA
Marketing start 2026-06-24
Substance ICOSAPENT ETHYL
Active strength 1 g/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A218949-001 ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2026-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218949-001 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 2026-09-14 22:38:34 2026-08 A218949-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2026-06-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218949-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2026-06-24 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218949-001 ICOSAPENT ETHYL 1GM CAPSULE / ORAL AB 2026-06-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A218949-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218949-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218949-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 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.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-812-08 59651081208 120 CAPSULE in 1 BOTTLE (59651-812-08) 120 capsule 2026-06-24 No No Current