NDC 0480-0127

Icosapent Ethyl

Icosapent Ethyl

Icosapent Ethyl is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals, Inc.. The primary component is Icosapent Ethyl.

Product ID0480-0127_25592b4b-64f3-4a20-b316-1574ace11c09
NDC0480-0127
Product TypeHuman Prescription Drug
Proprietary NameIcosapent Ethyl
Generic NameIcosapent Ethyl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2022-12-15
Marketing CategoryANDA /
Application NumberANDA209525
Labeler NameTeva Pharmaceuticals, Inc.
Substance NameICOSAPENT ETHYL
Active Ingredient Strength1 g/1
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0480-0127-89

120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0127-89)
Marketing Start Date2022-12-15
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
0480-0126Icosapent EthylIcosapent Ethyl
0480-0127Icosapent EthylIcosapent Ethyl
60505-4033Icosapent EthylIcosapent Ethyl
63629-9311Icosapent EthylIcosapent Ethyl
72603-129Icosapent EthylIcosapent Ethyl
43598-267IcosapentIcosapent Ethyl
63629-9312IcosapentIcosapent Ethyl
52937-001Vascepaicosapent ethyl
52937-003Vascepaicosapent ethyl
52937-101Vascepaicosapent ethyl
63629-8247Vascepaicosapent ethyl

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.