FDA.reportPublic FDA data

Vascepa

Product NDC
63629-8247
11-digit product format
636298247
Labeler code
63629
Product ID
63629-8247_322776f8-84f9-4198-b95c-353e9df6c70d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
icosapent ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA202057
Marketing category
NDA
Marketing start
2012-10-01
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

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
63629-8247-1Vascepa30 in 1 BOTTLECAPSULE307
63629-8247-2Vascepa60 in 1 BOTTLECAPSULE607
63629-8247-3Vascepa120 in 1 BOTTLECAPSULE1207
63629-8247-4Vascepa90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8247VASCEPA (ICOSAPENT ETHYL) CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 4 package rows20240511_d245ddab-d81b-44bd-90d7-0e4d446d9bf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSNd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304985Vascepa 1 GM Oral CapsulePSNd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304985icosapent ethyl 1000 MG Oral Capsule [Vascepa]SBDd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304979icosapent ethyl 1000 MG Oral CapsuleSCDd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304979icosapent ethyl 1 GM Oral CapsuleSYd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304985Vascepa 1 GM Oral CapsuleSYd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304985Vascepa 1000 MG Oral CapsuleSYd245ddab-d81b-44bd-90d7-0e4d446d9bf57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8247-16362982470130 CAPSULE in 1 BOTTLE (63629-8247-1) 30 capsule2026-04-070000-00-00NoNoCurrent
63629-8247-26362982470260 CAPSULE in 1 BOTTLE (63629-8247-2) 60 capsule2026-04-070000-00-00NoNoCurrent
63629-8247-363629824703120 CAPSULE in 1 BOTTLE (63629-8247-3) 120 capsule2026-04-070000-00-00NoNoCurrent
63629-8247-46362982470490 CAPSULE in 1 BOTTLE (63629-8247-4) 90 capsule2026-04-07NoNoHistorical