NDC 21695-778

Zetia

Ezetimibe

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

Product ID21695-778_582e1593-1e6c-4ce8-8bae-134fbc3a66f0
NDC21695-778
Product TypeHuman Prescription Drug
Proprietary NameZetia
Generic NameEzetimibe
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-27
Marketing CategoryNDA / NDA
Application NumberNDA021445
Labeler NameRebel Distributors Corp
Substance NameEZETIMIBE
Active Ingredient Strength10 mg/1
Pharm ClassesDecreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-778-90

90 TABLET in 1 BOTTLE (21695-778-90)
Marketing Start Date2009-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-778-90 [21695077890]

Zetia TABLET
Marketing CategoryNDA
Application NumberNDA021445
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-27
Inactivation Date2019-09-24

NDC 21695-778-30 [21695077830]

Zetia TABLET
Marketing CategoryNDA
Application NumberNDA021445
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-27
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

OpenFDA Data

SPL SET ID:582e1593-1e6c-4ce8-8bae-134fbc3a66f0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349556
  • 352304

    • 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
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