Icosapent Ethyl

Product NDC
72162-1000
11-digit product format
721621000
Labeler code
72162
Product ID
72162-1000_fac99b8e-6dff-47a2-918c-087f363c97ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icosapent Ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1000-2Icosapent Ethyl120 in 1 BOTTLECAPSULE120100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1000-2EA - Each72162-100062b5d381-ea08-40b9-b9ce-f6c987c1c43112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1000ICOSAPENT ETHYL CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20241228_0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSN0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf100
1304979icosapent ethyl 1000 MG Oral CapsuleSCD0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf100
1304979icosapent ethyl 1 GM Oral CapsuleSY0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1000-272162100002120 CAPSULE in 1 BOTTLE (72162-1000-2) 120 capsule2024-12-24NoNoCurrent