FDA.reportPublic FDA data

Icosapent Ethyl

Product NDC
71335-2842
11-digit product format
713352842
Labeler code
71335
Product ID
71335-2842_d97ec6a3-1912-4a16-b85a-ff78fd692e35
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2842-1Icosapent Ethyl120 in 1 BOTTLECAPSULE120100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2842-1EA - Each71335-2842caf52427-8b4d-4738-966e-c64acc8705f412025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSN582638e5-9881-409d-a455-041b5ba6892a100
1304979icosapent ethyl 1000 MG Oral CapsuleSCD582638e5-9881-409d-a455-041b5ba6892a100
1304979icosapent ethyl 1 GM Oral CapsuleSY582638e5-9881-409d-a455-041b5ba6892a100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2842-171335284201120 CAPSULE in 1 BOTTLE (71335-2842-1) 120 capsule2025-10-21NoNoCurrent