aripiprazole 10 MG Oral Tablet
1 INDICATIONS AND USAGE Aripiprazole Oral Tablets are indicated for the treatment of: Schizophrenia Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia ( 14.1 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette’s disorder ( 14.5 )
Ajanta Pharma Limited
ROUND PINK AZ 3
AZ 3 ROUND 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 Tablet, USP Presentations Tablet Strength Tablet Color/Shape Tablet Markings Pack Size NDC Code 2 mg white round “AZ” and “1” Bottle of 30 with a child-resistant closure Bottle of 500 27241-051-03 27241-051-08 5 mg yellow slightly mottled round “AZ” and “2” Bottle of 30 with a child-resistant closure Bottle of 500 27241-052-03 27241-052-08 10 mg pink slightly mottled round “AZ” and “3” Bottle of 30 with a child-resistant closure Bottle of 500 27241-053-03 27241-053-08 15 mg pink slightly mottled square “AZ” and “4” Bottle of 30 with a child-resistant closure Bottle of 500 27241-054-03 27241-054-08 20 mg pink slightly mottled modified rectangular “AZ5” Bottle of 30 with a child-resistant closure Bottle of 500 27241-055-03 27241-055-08 30 mg pink slightly mottled round “AZ6” Bottle of 30 with a child-resistant closure Bottle of 500 27241-056-03 27241-056-08 16.2 Storage Tablets 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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