aripiprazole 5 mg
1 INDICATIONS & USAGE Aripiprazole Oral 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 tablets are an atypical antipsychotic. The oral formulation is 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 )
ascend laboratories, llc
RECTANGLE BLUE ARI 5
ARI 5 RECTANGLE BLUE
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aripiprazole 5 mg
ascend laboratories, llc
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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 “ARI” and “2” 30’s HDPE Container 67877-430-03 100’s HDPE Container 67877-430-01 500’s HDPE Container 67877-430-05 10’s blister pack 67877-430-33 Carton pack of 100 tablets (10 × 10’s blister pack) 67877-430-38 7’s blister pack 67877-430-32 Carton pack of 7 tablets (1 × 7’s blister pack) 67877-430-32 5 mg blue modified rectangle “ARI” and “5” 30’s HDPE Container 67877-431-03 100’s HDPE Container 67877-431-01 500’s HDPE Container 67877-431-05 10’s blister pack 67877-431-33 Carton pack of 100 tablets (10 × 10’s blister pack) 67877-431-38 7’s blister pack 67877-431-32 Carton pack of 7 tablets (1 × 7’s blister pack) 67877-431-32 10 mg pink modified rectangle “ARI” and “10” 30’s HDPE Container 67877-432-03 100’s HDPE Container 67877-432-01 500’s HDPE Container 67877-432-05 10’s blister pack 67877-432-33 Carton pack of 100 tablets (10 × 10’s blister pack) 67877-432-38 7’s blister pack 67877-432-32 Carton pack of 7 tablets (1 × 7’s blister pack) 67877-432-32 15 mg yellow round “ARI” and “15” 30’s HDPE Container 67877-433-03 100’s HDPE Container 67877-433-01 500’s HDPE Container 67877-433-05 10’s blister pack 67877-433-33 Carton pack of 100 tablets (10 × 10’s blister pack) 67877-433-38 7’s blister pack 67877-433-32 Carton pack of 7 tablets (1 × 7’s blister pack) 67877-433-32 20 mg white to off-white round “ARI” and “20” 30’s HDPE Container 67877-434-03 100’s HDPE Container 67877-434-01 500’s HDPE Container 67877-434-05 10’s blister pack 67877-434-33 Carton pack of 100 tablets (10 × 10’s blister pack) 67877-434-38 30 mg pink round “ARI” and “30” 30’s HDPE Container 67877-435-03 100’s HDPE Container 67877-435-01 500’s HDPE Container 67877-435-05 10’s blister pack 67877-435-33 Carton pack of 100 tablets (10 × 10’s blister pack) 67877-435-38 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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