aripiprazole 5 mg
1 INDICATIONS AND USAGE Aripiprazole tablets are indicated for the treatment of: Schizophrenia [see Clinical Studies ( 14.1 )] Irritability Associated with Autistic Disorder [see Clinical Studies ( 14.4 )] Treatment of Tourette’s Disorder [ see Clinical Studies ( 14.5 )] 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 tablets are an atypical antipsychotic. The oral formulation is indicated for: Schizophrenia ( 14.1 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette’s disorder ( 14.5 )
apotex corp
RECTANGLE BLUE A 5
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
ARIPIPRAZOLE Tablets, USP 2 mg are available for oral administration as green, rectangular, slightly biconvex tablets, engraved "2" on one side and "A" on the other side. Bottles of 30 (NDC 60505-3075-3) Bottles of 1,000 (NDC 60505-3075-8)
ARIPIPRAZOLE Tablets, USP 5 mg are available for oral administration as blue, rectangular, slightly biconvex tablets, engraved “5” on one side and “A” on the other side. Bottles of 30 (NDC 60505-2673-3) Bottles of 1,000 (NDC 60505-2673-8)
ARIPIPRAZOLE Tablets, USP 10 mg are available for oral administration as pink, rectangular, slightly biconvex tablets, engraved “10” on one side and “A” on the other side. Bottles of 30 (NDC 60505-2674-3) Bottles of 1,000 (NDC 60505-2674-8)
ARIPIPRAZOLE Tablets, USP 15 mg are available for oral administration as yellow, round, slightly biconvex tablets, engraved “ARI” over “15” on one side and “APO” on the other side. Bottles of 30 (NDC 60505-2675-3) Bottles of 1,000 (NDC 60505-2675-8)
ARIPIPRAZOLE Tablets, USP 20 mg are available for oral administration as white to off-white, round, slightly biconvex tablets, engraved “ARI” over “20” on one side and “APO” on the other side. Bottles of 30 (NDC 60505-2676-3) Bottles of 1,000 (NDC 60505-2676-8)
ARIPIPRAZOLE Tablets, USP 30 mg are available for oral administration as pink, round, slightly biconvex tablets, engraved “ARI” over “30” on one side and “APO” on the other side. Bottles of 30 (NDC 60505-2677-3) Bottles of 1,000 (NDC 60505-2677-8) 16.2 Storage Tablets Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
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