FDA.reportPublic FDA data

Icosapent Ethyl

Product NDC
69680-186
11-digit product format
696800186
Labeler code
69680
Product ID
69680-186_cd69c4f4-24bc-4a95-89af-8afacbed1d08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icosapent Ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Vitruvias Therapeutics, Inc.
Application
ANDA219156
Marketing category
ANDA
Marketing start
2025-10-20
Substance
ICOSAPENT ETHYL
Active strength
1 g/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Icosapent Ethyl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ICOSAPENT ETHYL1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GC8A4PAYH
Rxcui1304979

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6766515-27b8-72de-2010-167151236aceProduct name720251021
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69680-186-92Icosapent Ethyl120 in 1 BOTTLECAPSULE1201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSN4c3e26d6-9297-42ad-94b4-04e394155b411
1304979icosapent ethyl 1000 MG Oral CapsuleSCD4c3e26d6-9297-42ad-94b4-04e394155b411
1304979icosapent ethyl 1 GM Oral CapsuleSY4c3e26d6-9297-42ad-94b4-04e394155b411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69680-186-9269680018692120 CAPSULE in 1 BOTTLE (69680-186-92) 120 capsule2025-10-20NoNoCurrent