Ezetimibe
These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS. EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
b6e77d9b-a553-63e0-e053-2a95a90a18fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
Orient Pharma Co., Ltd.
DUNS: 658849810
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 Code76333-170
Application NumberANDA215693
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT