ARIPIPRAZOLE tablet, orally disintegrating

Aripiprazole by

Drug Labeling and Warnings

Aripiprazole by is a Prescription medication manufactured, distributed, or labeled by SQUARE PHARMACEUTICALS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ARIPIPRAZOLE 
aripiprazole tablet, orally disintegrating

Product 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	06/20/2022
2	NDC: 76483-100-01	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022
3	NDC: 76483-100-02	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022
4	NDC: 76483-100-03	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090165	06/20/2022

ARIPIPRAZOLE 
aripiprazole tablet, orally disintegrating

Product 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	06/20/2022
2	NDC: 76483-101-01	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022
3	NDC: 76483-101-02	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022
4	NDC: 76483-101-03	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090165	06/20/2022

ARIPIPRAZOLE 
aripiprazole tablet, orally disintegrating

Product 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	06/20/2022
2	NDC: 76483-102-01	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022
3	NDC: 76483-102-02	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022
4	NDC: 76483-102-03	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090165	06/20/2022

ARIPIPRAZOLE 
aripiprazole tablet, orally disintegrating

Product 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	06/20/2022
2	NDC: 76483-103-01	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022
3	NDC: 76483-103-02	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022
4	NDC: 76483-103-03	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090165	06/20/2022

Labeler - SQUARE PHARMACEUTICALS LIMITED (731487153)

Registrant - SQUARE PHARMACEUTICALS LIMITED (731487153)

Establishment
Name	Address	ID/FEI	Business Operations
SQUARE PHARMACEUTICALS LIMITED		731487153	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)