aripiprazole 15 MG Oral Tablet
1 INDICATIONS & USAGE Aripiprazole Oral Tablets are indicated for the treatment of: • Schizophrenia • Irritability Associated with Autistic Disorder ( 14.4 ) • Treatment of Tourette’s disorder ( 14.5) 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 )
Macleods Pharmaceuticals Limited
ROUND YELLOW CL 75
CL 75 ROUND YELLOW
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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 green modified rectangle “CL 72” ” Bottle of 30 33342-122-07 Bottle of 100 33342-122-11 Blister of 100 33342-122-12 5 mg blue modified rectangle “CL 73” Bottle of 30 33342-123-07 Bottle of 100 33342-123-11 Blister of 100 33342-123-12 10 mg pink modified rectangle “CL 74” Bottle of 30 33342-124-07 Bottle of 100 33342-124-11 Blister of 100 33342-124-12 15 mg yellow round “CL 75” Bottle of 30 33342-125-07 Bottle of 100 33342-125-11 Blister of 100 33342-125-12 20 mg white to off-white round “CL 76” Bottle of 30 33342-126-07 Bottle of 100 33342-126-11 Blister of 100 33342-126-12 30 mg pink round “CL 78” Bottle of 30 33342-127-07 Bottle of 100 33342-127-11 Blister of 100 33342-127-12 16.2 Storage Tablets Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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