ARIPIPRAZOLE tablet, orally disintegrating
Aripiprazole by
Drug Labeling and Warnings
Aripiprazole by is a Prescription medication manufactured, distributed, or labeled by SQUARE PHARMACEUTICALS LIMITED, SQUARE PHARMACEUTICALS LIMITED, Dhaka unit. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 76483-100-00
Aripiprazole Orally Disintegrating Tablets, USP 10 mg
30 Tablets
Rx Only
NDC: 76483-100-01
Aripiprazole Orally Disintegrating Tablets, USP 10 mg
60 Tablets
Rx Only
NDC: 76483-100-02
Aripiprazole Orally Disintegrating Tablets, USP 10 mg
90 Tablets
Rx Only
NDC: 76483-100-03
Aripiprazole Orally Disintegrating Tablets, USP 10 mg
120 Tablets
Rx Only
NDC: 76483-101-00
Aripiprazole Orally Disintegrating Tablets, USP 15 mg
30 Tablets
Rx Only
NDC: 76483-101-01
Aripiprazole Orally Disintegrating Tablets, USP 15 mg
60 Tablets
Rx Only
NDC: 76483-101-02
Aripiprazole Orally Disintegrating Tablets, USP 15 mg
90 Tablets
Rx Only
NDC: 76483-101-03
Aripiprazole Orally Disintegrating Tablets, USP 15 mg
120 Tablets
Rx Only
NDC: 76483-102-00
Aripiprazole Orally Disintegrating Tablets, USP 20 mg
30 Tablets
Rx Only
NDC: 76483-102-01
Aripiprazole Orally Disintegrating Tablets, USP 20 mg
60 Tablets
Rx Only
NDC: 76483-102-02
Aripiprazole Orally Disintegrating Tablets, USP 20 mg
90 Tablets
Rx Only
NDC: 76483-102-03
Aripiprazole Orally Disintegrating Tablets, USP 20 mg
120 Tablets
Rx Only
NDC: 76483-103-00
Aripiprazole Orally Disintegrating Tablets, USP 30 mg
30 Tablets
Rx Only
NDC: 76483-103-01
Aripiprazole Orally Disintegrating Tablets, USP 30 mg
60 Tablets
Rx Only
NDC: 76483-103-02
Aripiprazole Orally Disintegrating Tablets, USP 30 mg
90 Tablets
Rx Only
NDC: 76483-103-03
Aripiprazole Orally Disintegrating Tablets, USP 30 mg
120 Tablets
Rx Only
Aripiprazole Orally Disintegrating Tablets 10 mg (30 Tablets in 1 Carton)
Each orally disintegrating tablet contains 10 mg aripiprazole USP
NDC: 76483-100-04
Rx Only
Aripiprazole Orally Disintegrating Tablets 15 mg (30 Tablets in 1 Carton)
Each orally disintegrating tablet contains 15 mg aripiprazole USP
NDC: 76483-101-04
Rx Only
Aripiprazole Orally Disintegrating Tablets, 20 mg (30 Tablets in 1 Carton)
Each orally disintegrating tablet contains 20 mg aripiprazole USP
NDC: 76483-102-04
Rx Only
Aripiprazole Orally Disintegrating Tablets 30 mg (30 Tablets in 1 Carton)
Each orally disintegrating tablet contains 30 mg aripiprazole USP
NDC: 76483-103-04
Rx Only
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INGREDIENTS AND APPEARANCE
ARIPIPRAZOLE
aripiprazole tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 76483-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78) ARIPIPRAZOLE 10 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CALCIUM STEARATE (UNII: 776XM7047L) CROSPOVIDONE (UNII: 2S7830E561) PEPPERMINT (UNII: V95R5KMY2B) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape CAPSULE Size 8mm Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;41 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 76483-100-00 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 2 NDC: 76483-100-01 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 3 NDC: 76483-100-02 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 4 NDC: 76483-100-03 120 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 5 NDC: 76483-100-04 30 in 1 CARTON; Type 0: Not a Combination Product 02/22/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090165 07/20/2022 ARIPIPRAZOLE
aripiprazole tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 76483-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78) ARIPIPRAZOLE 15 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CALCIUM STEARATE (UNII: 776XM7047L) CROSPOVIDONE (UNII: 2S7830E561) PEPPERMINT (UNII: V95R5KMY2B) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND Size 8mm Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;42 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 76483-101-00 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 2 NDC: 76483-101-01 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 3 NDC: 76483-101-02 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 4 NDC: 76483-101-03 120 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 5 NDC: 76483-101-04 30 in 1 CARTON; Type 0: Not a Combination Product 02/22/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090165 07/20/2022 ARIPIPRAZOLE
aripiprazole tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 76483-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78) ARIPIPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CALCIUM STEARATE (UNII: 776XM7047L) CROSPOVIDONE (UNII: 2S7830E561) MANNITOL (UNII: 3OWL53L36A) PEPPERMINT (UNII: V95R5KMY2B) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OCTAGON (8 SIDED) (BARREL) Size 8mm Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;43 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 76483-102-00 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 2 NDC: 76483-102-01 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 3 NDC: 76483-102-02 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 4 NDC: 76483-102-03 120 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 5 NDC: 76483-102-04 30 in 1 CARTON; Type 0: Not a Combination Product 02/22/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090165 07/20/2022 ARIPIPRAZOLE
aripiprazole tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 76483-103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78) ARIPIPRAZOLE 30 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CALCIUM STEARATE (UNII: 776XM7047L) CROSPOVIDONE (UNII: 2S7830E561) MANNITOL (UNII: 3OWL53L36A) PEPPERMINT (UNII: V95R5KMY2B) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 76483-103-00 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 2 NDC: 76483-103-01 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 3 NDC: 76483-103-02 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 4 NDC: 76483-103-03 120 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2022 5 NDC: 76483-103-04 30 in 1 CARTON; Type 0: Not a Combination Product 02/22/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090165 07/20/2022 Labeler - SQUARE PHARMACEUTICALS LIMITED (731487153) Registrant - SQUARE PHARMACEUTICALS LIMITED (731487153) Establishment Name Address ID/FEI Business Operations SQUARE PHARMACEUTICALS LIMITED, Dhaka unit 850366520 ANALYSIS(76483-100, 76483-101, 76483-102, 76483-103) , LABEL(76483-100, 76483-101, 76483-102, 76483-103) , MANUFACTURE(76483-100, 76483-101, 76483-102, 76483-103) , PACK(76483-100, 76483-101, 76483-102, 76483-103)
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