cilostazol
Cilostazol Tablets, USP Rx only These highlights do not include all the information needed to use CILOSTAZOL TABLETS safely and effectively. See full prescribing information for CILOSTAZOL TABLETS. Initial U.S. Approval: 1999
Approved
Approval ID
dc7c2c25-36a1-e3fd-e053-2995a90adabc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
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 Code42291-453
Application NumberANDA077030
Product Classification
M
Marketing Category
C73584
G
Generic Name
cilostazol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CILOSTAZOLActive
Quantity: 100 mg in 1 1
Code: N7Z035406B
Classification: ACTIB