Icosapent Ethyl

Product NDC
72603-129
11-digit product format
726030129
Labeler code
72603
Product ID
72603-129_757a9559-dad4-4397-93ac-d81fbaf92754
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icosapent Ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA209457
Marketing category
ANDA
Marketing start
2020-11-04
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
72603-129-01Icosapent Ethyl120 in 1 BOTTLECAPSULE1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-129-01EA - Each72603-129e692af8c-784f-482c-b59e-df9691c1c43b12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-129ICOSAPENT ETHYL CAPSULE [NORTHSTAR RX LLC]2Current NDC, Legacy NDC, 1 package rows20231223_45f8bb41-bdb1-4afc-83ec-9dc69720ee9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSN45f8bb41-bdb1-4afc-83ec-9dc69720ee9c2
1304979icosapent ethyl 1000 MG Oral CapsuleSCD45f8bb41-bdb1-4afc-83ec-9dc69720ee9c2
1304979icosapent ethyl 1 GM Oral CapsuleSY45f8bb41-bdb1-4afc-83ec-9dc69720ee9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72603-129-0172603012901120 CAPSULE in 1 BOTTLE (72603-129-01) 120 capsule2022-01-310000-00-00NoNoCurrent