DailyMed - ARIPIPRAZOLE tablet, orally disintegrating

NDC Code(s): 76483-100-00, 76483-100-01, 76483-100-02, 76483-100-03, view more
76483-100-04, 76483-101-00, 76483-101-01, 76483-101-02, 76483-101-03, 76483-101-04, 76483-102-00, 76483-102-01, 76483-102-02, 76483-102-03, 76483-102-04, 76483-103-00, 76483-103-01, 76483-103-02, 76483-103-03, 76483-103-04
Packager: SQUARE PHARMACEUTICALS LIMITED

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 2, 2023

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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

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

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

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)

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Published Date (What is this?)	Version	Files
Jul 6, 2023	3 (current)	download
Mar 7, 2023	2	download
Jun 20, 2022	1	download

	RxCUI	RxNorm NAME	RxTTY
1	643019	ARIPiprazole 10 MG Disintegrating Oral Tablet	PSN
2	643019	aripiprazole 10 MG Disintegrating Oral Tablet	SCD
3	643022	ARIPiprazole 15 MG Disintegrating Oral Tablet	PSN
4	643022	aripiprazole 15 MG Disintegrating Oral Tablet	SCD
5	643027	ARIPiprazole 20 MG Disintegrating Oral Tablet	PSN
6	643027	aripiprazole 20 MG Disintegrating Oral Tablet	SCD
7	643058	ARIPiprazole 30 MG Disintegrating Oral Tablet	PSN
8	643058	aripiprazole 30 MG Disintegrating Oral Tablet	SCD

Label: ARIPIPRAZOLE tablet, orally disintegrating

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	NDC
1	76483-100-00
2	76483-100-01
3	76483-100-02
4	76483-100-03
5	76483-100-04
6	76483-101-00
7	76483-101-01
8	76483-101-02
9	76483-101-03
10	76483-101-04
11	76483-102-00
12	76483-102-01
13	76483-102-02
14	76483-102-03
15	76483-102-04
16	76483-103-00
17	76483-103-01
18	76483-103-02
19	76483-103-03
20	76483-103-04

Label: ARIPIPRAZOLE tablet, orally disintegrating

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

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Safety

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ARIPIPRAZOLE tablet, orally disintegrating

Number of versions: 3

ARIPIPRAZOLE tablet, orally disintegrating

ARIPIPRAZOLE tablet, orally disintegrating

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ARIPIPRAZOLE tablet, orally disintegrating

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.