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 useInitial U.S. Approval: 2002
Approved
Approval ID
55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2025
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code82804-211
Application NumberANDA078560
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2025
FDA Product Classification
INGREDIENTS (6)
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT