FDA.reportPublic FDA data

Icosapent Ethyl

Product NDC
60429-005
11-digit product format
604290005
Labeler code
60429
Product ID
60429-005_36370268-ebc0-8ab1-e063-6394a90adc9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icosapent Ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA209437
Marketing category
ANDA
Marketing start
2021-06-30
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-005-12Icosapent Ethyl120 in 1 BOTTLECAPSULE1201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSN3637187f-70bc-eb31-e063-6294a90ad3cb1
1304979icosapent ethyl 1000 MG Oral CapsuleSCD3637187f-70bc-eb31-e063-6294a90ad3cb1
1304979icosapent ethyl 1 GM Oral CapsuleSY3637187f-70bc-eb31-e063-6294a90ad3cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60429-005-1260429000512120 CAPSULE in 1 BOTTLE (60429-005-12) 120 capsule2025-03-31NoNoCurrent