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
a6292311-9cb2-49ff-b8bf-12e2dbd196cd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 2
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 Code0093-2065
Application NumberANDA077027
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cilostazol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (7)
CILOSTAZOLActive
Quantity: 50 mg in 1 1
Code: N7Z035406B
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Cilostazol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-2064
Application NumberANDA077027
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cilostazol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (7)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CILOSTAZOLActive
Quantity: 100 mg in 1 1
Code: N7Z035406B
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT