NDC 52937-003

Vascepa

Icosapent Ethyl

Vascepa is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Amarin Pharma Inc.. The primary component is Icosapent Ethyl.

Product ID52937-003_21c3862a-0006-4668-aabf-e05383634bf3
NDC52937-003
Product TypeHuman Prescription Drug
Proprietary NameVascepa
Generic NameIcosapent Ethyl
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-09-16
Marketing CategoryNDA / NDA
Application NumberNDA202057
Labeler NameAmarin Pharma Inc.
Substance NameICOSAPENT ETHYL
Active Ingredient Strength500 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 52937-003-16

1 BLISTER PACK in 1 CARTON (52937-003-16) > 16 CAPSULE in 1 BLISTER PACK
Marketing Start Date2016-09-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52937-003-40 [52937000340]

Vascepa CAPSULE
Marketing CategoryNDA
Application NumberNDA202057
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-16

NDC 52937-003-16 [52937000316]

Vascepa CAPSULE
Marketing CategoryNDA
Application NumberNDA202057
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-16

Drug Details

Active Ingredients

IngredientStrength
ICOSAPENT ETHYL500 mg/1

OpenFDA Data

SPL SET ID:9c1a2828-1583-4414-ab22-a60480e8e508
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1811182
  • 1811180
  • 1304979
  • 1304985

    • Medicade Reported Pricing

    52937000340 VASCEPA 0.5 GM CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Vascepa" or generic name "Icosapent Ethyl"

    NDCBrand NameGeneric Name
    52937-001Vascepaicosapent ethyl
    52937-003Vascepaicosapent ethyl
    52937-101Vascepaicosapent ethyl
    63629-8247Vascepaicosapent ethyl
    43598-267IcosapentIcosapent Ethyl
    63629-9312IcosapentIcosapent Ethyl
    0054-0508Icosapent EthylIcosapent Ethyl
    0480-0126Icosapent EthylIcosapent Ethyl
    0480-0127Icosapent EthylIcosapent Ethyl
    60505-4033Icosapent EthylIcosapent Ethyl
    63629-9311Icosapent EthylIcosapent Ethyl
    72603-129Icosapent EthylIcosapent Ethyl

    Trademark Results [Vascepa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VASCEPA
    VASCEPA
    86655265 5001304 Live/Registered
    Amarin Pharmaceuticals Ireland Limited
    2015-06-08
    VASCEPA
    VASCEPA
    85202744 4238272 Live/Registered
    Amarin Pharmaceuticals Ireland Limited
    2010-12-21
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