FDA.reportPublic FDA data

Vascepa

Product NDC
52937-005
11-digit product format
529370005
Labeler code
52937
Product ID
52937-005_86b35fe3-d1cf-478e-849b-2ea0c87bda33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
icosapent ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Amarin Pharma Inc.
Application
NDA202057
Marketing category
NDA
Marketing start
2025-12-05
Substance
ICOSAPENT ETHYL
Active strength
1000 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ICOSAPENT ETHYL1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GC8A4PAYH
Rxcui1304979, 1304985, 1811180, 1811182

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
52937-005-20Vascepa120 in 1 BOTTLECAPSULE12021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52937-005-20EA - Each52937-0050b03bec3-91cb-44c5-bca0-cf4a7fd9680012026-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
icosapent ethylACTIVE INGREDIENT6GC8A4PAYHVASCEPA (ICOSAPENT ETHYL) CAPSULE [AMARIN PHARMA INC.]10
icosapentACTIVE MOIETYAAN7QOV9EAVASCEPA (ICOSAPENT ETHYL) CAPSULE [AMARIN PHARMA INC.]10
GelatinINACTIVE INGREDIENT2G86QN327LVASCEPA (ICOSAPENT ETHYL) CAPSULE [AMARIN PHARMA INC.]10
GlycerinINACTIVE INGREDIENTPDC6A3C0OXVASCEPA (ICOSAPENT ETHYL) CAPSULE [AMARIN PHARMA INC.]10
MaltitolINACTIVE INGREDIENTD65DG142WKVASCEPA (ICOSAPENT ETHYL) CAPSULE [AMARIN PHARMA INC.]10
SorbitolINACTIVE INGREDIENT506T60A25RVASCEPA (ICOSAPENT ETHYL) CAPSULE [AMARIN PHARMA INC.]10
TocopherolINACTIVE INGREDIENTR0ZB2556P8VASCEPA (ICOSAPENT ETHYL) CAPSULE [AMARIN PHARMA INC.]10
WaterINACTIVE INGREDIENT059QF0KO0RVASCEPA (ICOSAPENT ETHYL) CAPSULE [AMARIN PHARMA INC.]10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1811180icosapent ethyl 0.5 GM Oral CapsulePSN9c1a2828-1583-4414-ab22-a60480e8e50821
1304979icosapent ethyl 1 GM Oral CapsulePSN9c1a2828-1583-4414-ab22-a60480e8e50821
1811182Vascepa 0.5 GM Oral CapsulePSN9c1a2828-1583-4414-ab22-a60480e8e50821
1304985Vascepa 1 GM Oral CapsulePSN9c1a2828-1583-4414-ab22-a60480e8e50821
1304985icosapent ethyl 1000 MG Oral Capsule [Vascepa]SBD9c1a2828-1583-4414-ab22-a60480e8e50821
1811182icosapent ethyl 500 MG Oral Capsule [Vascepa]SBD9c1a2828-1583-4414-ab22-a60480e8e50821
1304979icosapent ethyl 1000 MG Oral CapsuleSCD9c1a2828-1583-4414-ab22-a60480e8e50821
1811180icosapent ethyl 500 MG Oral CapsuleSCD9c1a2828-1583-4414-ab22-a60480e8e50821
1811180icosapent ethyl 0.5 GM Oral CapsuleSY9c1a2828-1583-4414-ab22-a60480e8e50821
1304979icosapent ethyl 1 GM Oral CapsuleSY9c1a2828-1583-4414-ab22-a60480e8e50821
1811182Vascepa 0.5 GM Oral CapsuleSY9c1a2828-1583-4414-ab22-a60480e8e50821
1304985Vascepa 1 GM Oral CapsuleSY9c1a2828-1583-4414-ab22-a60480e8e50821
1304985Vascepa 1000 MG Oral CapsuleSY9c1a2828-1583-4414-ab22-a60480e8e50821
1811182Vascepa 500 MG Oral CapsuleSY9c1a2828-1583-4414-ab22-a60480e8e50821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52937-005-2052937000520120 CAPSULE in 1 BOTTLE (52937-005-20) 120 capsule2025-12-05NoNoHistorical