Cilostazol
These highlights do not include all the information needed to use CILOSTAZOL TABLETS safely and effectively. See full prescribing information for CILOSTAZOL TABLETS. CILOSTAZOL tablets, for oral useInitial U.S. Approval: 1999
Approved
Approval ID
50fc64ac-7eb3-4bab-8de2-83cd5404d169
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2016
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cilostazol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-4123
Application NumberANDA077024
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cilostazol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2016
FDA Product Classification
INGREDIENTS (7)
CILOSTAZOLActive
Quantity: 100 mg in 1 1
Code: N7Z035406B
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT