aripiprazole 2 mg
1 INDICATIONS AND USAGE Aripiprazole is indicated for the treatment of: • Schizophrenia • Irritability Associated with Autistic Disorder • Treatment of Tourette’s Disorder 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 formulations are indicated for: • Schizophrenia (14.1) • Irritability Associated with Autistic Disorder (14.4) • Treatment of Tourette’s disorder (14.5)
alembic pharmaceuticals inc.
RECTANGLE GREEN 251
251 RECTANGLE GREEN
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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 Off white to cream modified rectangle “251” Bottle of 30 Bottle of 60 Bottle of 100 Bottle of 180 Bottle of 500 Bottle of 1000 Caton of 100 (10x10) blisters 62332-097-30 62332-097-60 62332-097-31 62332-097-45 62332-097-71 62332-097-91 62332-097-10 5 mg off-white to light pink modified rectangle “250” Bottle of 30 Bottle of 60 Bottle of 100 Bottle of 180 Bottle of 500 Bottle of 1000 Caton of 100 (10x10) blisters 62332-098-30 62332-098-60 62332-098-31 62332-098-45 62332-098-71 62332-098-91 62332-098-10 10 mg white to off white modified rectangle “252” Bottle of 30 Bottle of 100 Bottle of 500 Bottle of 1000 Caton of 100 (10x10) blisters 62332-099-30 62332-099-31 62332-099-71 62332-099-91 62332-099-10 15 mg white to off white round “253” Bottle of 30 Bottle of 100 Bottle of 500 Bottle of 1000 Caton of 100 (10x10) blisters 62332-100-30 62332-100-31 62332-100-71 62332-100-91 62332-100-10 20 mg white to off white round “L254” Bottle of 30 Bottle of 100 Bottle of 500 Bottle of 1000 Caton of 100 (10x10) blisters 62332-101-30 62332-101-31 62332-101-71 62332-101-91 62332-101-10 30 mg white to off white round “L255” Bottle of 30 Bottle of 100 Bottle of 500 Bottle of 1000 Caton of 100 (10x10) blisters 62332-102-30 62332-102-31 62332-102-71 62332-102-91 62332-102-10 16.2 Storage Tablets Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].
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