aripiprazole 15 MG Oral Tablet
1 INDICATIONS AND USAGE Aripiprazole tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's disorder ( 14.5 )
accord healthcare, inc.
ROUND YELLOW A15
A15 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
ARIPIPRAZOLE tablets, USP have markings on one side an are available in the strengths and packages listed in Table 32. Bottles of 30’s & 100’s count comes with child-resistant package. Table 32:
ARIPIPRAZOLE Tablet, USP Presentations Tablet Strength Tablet Color/Shape Tablet Markings Pack Size NDC Code 2 mg green modified rectangle “A2” on one side and another side is plain Bottle of 30 Bottle of 100 Bottle of 500 Blister of 100 16729-278-10 16729-278-01 16729-278-16 16729-278-46 5 mg blue modified rectangle “A5” on one side and another side is plain Bottle of 30 Bottle of 100 Bottle of 500 Blister of 100 16729-279-10 16729-279-01 16729-279-16 16729-279-46 10 mg pink modified rectangle “A10” on one side and another side is plain Bottle of 30 Bottle of 100 Bottle of 500 Blister of 100 16729-280-10 16729-280-01 16729-280-16 16729-280-46 15 mg yellow round “A15” on one side and another side is plain Bottle of 30 Bottle of 100 Bottle of 500 Blister of 100 16729-281-10 16729-281-01 16729-281-16 16729-281-46 20 mg white to off white round “A20” on one side and another side is plain Bottle of 30 Bottle of 100 Bottle of 500 Blister of 100 16729-282-10 16729-282-01 16729-282-16 16729-282-46 30 mg pink round “A30” on one side and another side is plain Bottle of 30 Bottle of 100 Bottle of 500 Blister of 100 16729-283-10 16729-283-01 16729-283-16 16729-283-46 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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