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
NDC Product Code0093-2065
Application NumberANDA077027
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 31, 2022
Generic NameCilostazol
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
NDC Product Code0093-2064
Application NumberANDA077027
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 31, 2022
Generic NameCilostazol
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