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
55ae41fb-6c59-4f41-bdc6-db7f75e98e00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 20, 2018
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code71610-037
Application NumberANDA077021
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cilostazol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2018
FDA Product Classification
INGREDIENTS (6)
CILOSTAZOLActive
Quantity: 100 mg in 1 1
Code: N7Z035406B
Classification: ACTIB
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT