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
db0278e9-4ece-4aaf-9216-6bcbec58206a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2023
Manufacturers
FDA
Slate Run Pharmaceuticals, LLC
DUNS: 039452765
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 Code70436-156
Application NumberANDA077208
Product Classification
M
Marketing Category
C73584
G
Generic Name
cilostazol
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2021
FDA Product Classification
INGREDIENTS (5)
cilostazolActive
Quantity: 50 mg in 1 1
Code: N7Z035406B
Classification: ACTIB
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
cilostazol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-157
Application NumberANDA077208
Product Classification
M
Marketing Category
C73584
G
Generic Name
cilostazol
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2021
FDA Product Classification
INGREDIENTS (5)
cilostazolActive
Quantity: 100 mg in 1 1
Code: N7Z035406B
Classification: ACTIB
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT