PLETAL Tablet Ref.[49792] Active ingredients: Cilostazol

Source: FDA, National Drug Code (US)  Revision Year: 2017 

Product description

PLETAL (cilostazol) is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C20H27N5O2, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy]-3,4-dihydro-2(1H)-quinolinone, CAS-73963-72-1.

The structural formula is:

Cilostazol occurs as white to off-white crystals or as a crystalline powder that is slightly soluble in methanol and ethanol, and is practically insoluble in water, 0.1 N HCl, and 0.1 N NaOH.

PLETAL (cilostazol) tablets for oral administration are available in 50 mg triangular and 100 mg round, white debossed tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: carboxymethylcellulose calcium, corn starch, hydroxypropyl methylcellulose 2910, magnesium stearate, and microcrystalline cellulose.

Dosage Forms and Strengths

PLETAL is available as 50 mg triangular and 100 mg round, white debossed tablets.

How Supplied

PLETAL is supplied as 50 mg and 100 mg tablets.

The 50 mg tablets are white, triangular, debossed with PLETAL 50, and provided in bottles of 60 tablets (NDC 59148-003-16).

The 100 mg tablets are white, round, debossed with PLETAL 100, and provided in bottles of 60 tablets (NDC 59148-002-16).

Manufactured for: OTSUKA AMERICA PHARMACEUTICAL, INC., Rockville, MD 20850

Manufactured by: OTSUKA PHARMACEUTICAL CO., LTD., Tokushima 771-0182, Japan

Drugs

Drug Countries
PLETAL Germany, Turkey, United Kingdom

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