Ezetimibe and Simvastatin
These highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE and SIMVASTATIN tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
2ce219a2-1eeb-4ece-bb87-3810e593ca51
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ezetimibe and Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4772
Application NumberANDA209222
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ezetimibe and Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2021
FDA Product Classification
INGREDIENTS (13)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
EZETIMIBEActive
Quantity: 10 mg in 1 1
Code: EOR26LQQ24
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SIMVASTATINActive
Quantity: 40 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT