Zetia
These highlights do not include all the information needed to use ZETIA safely and effectively. See full prescribing information for ZETIA. ZETIA (ezetimibe) TabletsInitial U.S. Approval: 2002
Approved
Approval ID
582e1593-1e6c-4ce8-8bae-134fbc3a66f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ezetimibe
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-778
Application NumberNDA021445
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ezetimibe
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2009
FDA Product Classification
INGREDIENTS (7)
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
EzetimibeActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
povidoneInactive
Code: FZ989GH94E
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT