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

Aripiprazole Orally Disintegrating Tablets, USP 10 mg; 120 Counts

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

Aripiprazole Orally Disintegrating Tablets, USP 15 mg; 120 Counts

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

Aripiprazole Orally Disintegrating Tablets, USP 20 mg; 120 Counts

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, USP 30 mg; 120 Counts

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, 10 mg (30 Tablets in 1 Carton)

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, 15 mg (30 Tablets in 1 Carton)

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 20 mg (30 Tablets in 1 Carton)

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

Aripiprazole Orally Disintegrating Tablets, 30 mg (30 Tablets in 1 Carton)

ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:76483-100
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090165	07/20/2022

ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:76483-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	15 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090165	07/20/2022

ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:76483-102
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	20 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090165	07/20/2022

ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:76483-103
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	30 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090165	07/20/2022

Labeler - SQUARE PHARMACEUTICALS LIMITED (731487153)

Registrant - SQUARE PHARMACEUTICALS LIMITED (731487153)

Name	Address	ID/FEI	Business Operations
Establishment
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)

ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL