Zetia
These highlights do not include all the information needed to use ZETIA safely and effectively. See full prescribing information for ZETIA. ZETIA (ezetimibe) Tablets Initial U.S. Approval: 2002
Approved
Approval ID
cb18564f-663f-4da2-9dd9-700ea9bdd398
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4719
Application NumberNDA021445
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ezetimibe
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2009
FDA Product Classification
INGREDIENTS (7)
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT