NDC 0054-0508

Icosapent Ethyl

Icosapent Ethyl

Icosapent Ethyl is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Icosapent Ethyl.

Product ID0054-0508_a0aa38fa-0276-48a1-aaf4-f4fbb7b0ffd7
Product TypeHuman Prescription Drug
Proprietary NameIcosapent Ethyl
Generic NameIcosapent Ethyl
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-11-04
Marketing CategoryANDA /
Application NumberANDA209457
Labeler NameHikma Pharmaceuticals USA Inc.
Active Ingredient Strength1 g/1
NDC Exclude FlagN
Listing Certified Through2021-12-31


NDC 0054-0508-23

120 CAPSULE in 1 BOTTLE (0054-0508-23)
Marketing Start Date2020-11-04
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0054-0508Icosapent EthylIcosapent Ethyl
52937-001Vascepaicosapent ethyl
52937-003Vascepaicosapent ethyl
52937-101Vascepaicosapent ethyl
63629-8247Vascepaicosapent ethyl

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