NDC 55154-5034

Zetia

Ezetimibe

Zetia is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health. The primary component is Ezetimibe.

Product ID55154-5034_4c4d1a53-3dba-40a6-ba99-965acebdb2e8
NDC55154-5034
Product TypeHuman Prescription Drug
Proprietary NameZetia
Generic NameEzetimibe
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-27
Marketing End Date2019-05-31
Marketing CategoryNDA / NDA
Application NumberNDA021445
Labeler NameCardinal Health
Substance NameEZETIMIBE
Active Ingredient Strength10 mg/1
Pharm ClassesDecreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]
NDC Exclude FlagN

Packaging

NDC 55154-5034-0

10 BLISTER PACK in 1 BAG (55154-5034-0) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2009-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-5034-0 [55154503400]

Zetia TABLET
Marketing CategoryNDA
Application NumberNDA021445
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-27
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

OpenFDA Data

SPL SET ID:029e1676-60c5-490a-b176-94f0f41f1077
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349556
  • 352304
    • UPC Code
  • 0055154503402

    • Pharmacological Class

    • Decreased Cholesterol Absorption [PE]
    • Dietary Cholesterol Absorption Inhibitor [EPC]

    NDC Crossover Matching brand name "Zetia" or generic name "Ezetimibe"

    NDCBrand NameGeneric Name
    21695-778ZetiaEzetimibe
    50090-0833ZetiaEzetimibe
    55154-5031ZetiaEzetimibe
    55154-5034ZetiaEzetimibe
    55154-5043ZetiaEzetimibe
    66582-414ZetiaZetia
    0591-3713EzetimibeEzetimibe
    0615-8300EzetimibeEzetimibe
    0781-5690EzetimibeEzetimibe
    0904-6664EzetimibeEzetimibe
    0904-7103EzetimibeEzetimibe
    16714-813EzetimibeEzetimibe
    16729-433EZETIMIBEEZETIMIBE
    31722-628EZETIMIBEEZETIMIBE
    42291-314EzetimibeEzetimibe
    49884-228EzetimibeEzetimibe
    50090-2717EzetimibeEzetimibe
    50090-3087EzetimibeEzetimibe
    50090-3402EzetimibeEzetimibe
    50090-3422EzetimibeEzetimibe
    50090-3657EzetimibeEzetimibe
    50228-379EzetimibeEzetimibe
    50268-298EzetimibeEzetimibe
    51660-200EzetimibeEzetimibe
    59651-052EzetimibeEzetimibe
    60429-982EzetimibeEzetimibe
    60505-2945EzetimibeEzetimibe
    60687-284EzetimibeEzetimibe
    60687-373EzetimibeEzetimibe

    Trademark Results [Zetia]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZETIA
    ZETIA
    76306514 2787086 Live/Registered
    MSD INTERNATIONAL GMBH
    2001-08-30
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.