FDA.reportPublic FDA data

Icosapent Ethyl

Product NDC
71335-3072
11-digit product format
713353072
Labeler code
71335
Product ID
71335-3072_c5b955ca-a0c6-4785-8796-7ec9ef54cd7b
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Icosapent Ethyl
Listing expiration
2027-12-31

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
71335-3072-1Icosapent Ethyl30 in 1 BOTTLECAPSULE301
71335-3072-2Icosapent Ethyl60 in 1 BOTTLECAPSULE601
71335-3072-3Icosapent Ethyl120 in 1 BOTTLECAPSULE1201
71335-3072-4Icosapent Ethyl90 in 1 BOTTLECAPSULE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSN07631e74-48e5-46ec-b8db-4b1bcf62d2831
1304979icosapent ethyl 1000 MG Oral CapsuleSCD07631e74-48e5-46ec-b8db-4b1bcf62d2831
1304979icosapent ethyl 1 GM Oral CapsuleSY07631e74-48e5-46ec-b8db-4b1bcf62d2831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3072-17133530720130 CAPSULE in 1 BOTTLE (71335-3072-1) 30 capsule2026-02-09NoNoHistorical
71335-3072-27133530720260 CAPSULE in 1 BOTTLE (71335-3072-2) 60 capsule2026-02-09NoNoHistorical
71335-3072-371335307203120 CAPSULE in 1 BOTTLE (71335-3072-3) 120 capsule2026-02-09NoNoHistorical
71335-3072-47133530720490 CAPSULE in 1 BOTTLE (71335-3072-4) 90 capsule2026-02-09NoNoHistorical