aripiprazole tablet
1 INDICATIONS AND USAGE Aripiprazole tablets are indicated for the treatment of: • Schizophrenia [ see CLINICAL STUDIES ( 14.1 ) ] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY ® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: • Schizophrenia ( 14.1 )
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RECTANGLE PINK SG 326
SG 326 RECTANGLE PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
ARIPIPRAZOLE Tablets, USP have markings on one side and are available in the strengths and packages listed in Table 32. Table 32:
ARIPIPRAZOLE Tablets, USP Presentations Tablet Strength Tablet Color/ Shape Tablet Markings Pack Size NDC Code 2 mg green modified rectangle “SG 324” Bottle of 30 Bottle of 500 43598-554-30 43598-554-05 5 mg blue modified rectangle “SG 325” Bottle of 30 Bottle of 500 43598-555-30 43598-555-05 10 mg pink modified rectangle “SG 326” Bottle of 30 Bottle of 500 43598-556-30 43598-556-05 15 mg pink round “SG 327” Bottle of 30 Bottle of 500 43598-557-30 43598-557-05 20 mg pink round “SG 328” Bottle of 30 Bottle of 500 43598-558-30 43598-558-05 30 mg pink round “SG 329” Bottle of 30 Bottle of 500 43598-559-30 43598-559-05 16.2 Storage Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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