Aripiprazole ODT

Package insert / prescribing information
Dosage form: tablet, orally disintegrating
Drug class: Atypical antipsychotics

Medically reviewed by Drugs.com. Last updated on Jun 1, 2022.

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
aripiprazole tablet, orally disintegrating

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARIPIPRAZOLE (ARIPIPRAZOLE)	ARIPIPRAZOLE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE
PEPPERMINT
MANNITOL

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
1	NDC:76483-100-00	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
2	NDC:76483-100-01	60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
3	NDC:76483-100-02	90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
4	NDC:76483-100-03	120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

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 LABEL	Item Code (Source)	NDC:76483-101
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARIPIPRAZOLE (ARIPIPRAZOLE)	ARIPIPRAZOLE	15 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE
PEPPERMINT
MANNITOL

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
1	NDC:76483-101-00	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
2	NDC:76483-101-01	60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
3	NDC:76483-101-02	90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
4	NDC:76483-101-03	120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

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 LABEL	Item Code (Source)	NDC:76483-102
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARIPIPRAZOLE (ARIPIPRAZOLE)	ARIPIPRAZOLE	20 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE
MANNITOL
PEPPERMINT

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
1	NDC:76483-102-00	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
2	NDC:76483-102-01	60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
3	NDC:76483-102-02	90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
4	NDC:76483-102-03	120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

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 LABEL	Item Code (Source)	NDC:76483-103
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARIPIPRAZOLE (ARIPIPRAZOLE)	ARIPIPRAZOLE	30 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE
MANNITOL
PEPPERMINT

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
1	NDC:76483-103-00	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
2	NDC:76483-103-01	60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
3	NDC:76483-103-02	90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
4	NDC:76483-103-03	120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

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	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)