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 use. Initial U.S. Approval: 1999
Approved
Approval ID
ceac1ae3-c343-28ca-c083-b748d21a15e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
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 Code60505-2521
Application NumberANDA077030
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 13, 2023
Generic Namecilostazol
INGREDIENTS (5)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
cilostazolActive
Quantity: 50 mg in 1 1
Code: N7Z035406B
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cilostazol
PRODUCT DETAILS
NDC Product Code60505-2522
Application NumberANDA077030
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 13, 2023
Generic Namecilostazol
INGREDIENTS (5)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
cilostazolActive
Quantity: 100 mg in 1 1
Code: N7Z035406B
Classification: ACTIB