MedPath

Cilostazol

Cilostazol Tablets, USP50 mg and 100 mgRx only

Approved
Approval ID

151d1497-7655-44ce-8e97-dd1cd91f686a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 15, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-5411
Application NumberANDA077022
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cilostazol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2011
FDA Product Classification

INGREDIENTS (6)

CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CILOSTAZOLActive
Quantity: 100 mg in 1 1
Code: N7Z035406B
Classification: ACTIM

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Cilostazol - FDA Drug Approval Details