NDC Code(s) : 59148-029-13, 59148-029-85, 59148-029-07, 59148-029-90, 59148-029-61, 59148-029-72, 59148-030-13, 59148-030-85, 59148-030-07, 59148-030-90, 59148-030-61, 59148-030-72, 59148-031-13, 59148-031-85, 59148-031-07, 59148-031-90, 59148-031-61, 59148-031-72, 59148-032-13, 59148-032-85, 59148-032-07, 59148-032-90, 59148-032-61, 59148-032-72, 59148-033-13, 59148-033-85, 59148-033-07, 59148-033-90, 59148-033-61, 59148-033-72, 59148-034-13, 59148-034-85, 59148-034-07, 59148-034-90, 59148-034-61, 59148-034-72
Packager : Otsuka America Pharmaceutical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Abilify MyCiteARIPIPRAZOLE TABLET WITH SENSOR
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-029
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78)
ARIPIPRAZOLE2 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
ALUMINUM OXIDE(UNII: LMI26O6933)
ALUMINUM(UNII: CPD4NFA903)
CUPROUS CHLORIDE(UNII: C955P95064)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
GOLD(UNII: 79Y1949PYO)
MAGNESIUM(UNII: I38ZP9992A)
SILICON(UNII: Z4152N8IUI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM(UNII: D1JT611TNE)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color GREEN (pale green) Score no score
Shape RECTANGLE (modified rectangle) Size 8 mm
Flavor Imprint Code DA;029;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-029-851 in 1 KIT 31/01/2018
1NDC:59148-029-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2NDC:59148-029-901 in 1 KIT 31/01/2018
2NDC:59148-029-077 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
3NDC:59148-029-611 in 1 KIT 19/12/2020
3NDC:59148-029-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
4NDC:59148-029-721 in 1 KIT 19/12/2020
4NDC:59148-029-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207202 01/31/2018
Abilify MyCiteARIPIPRAZOLE TABLET WITH SENSOR
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-030
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78)
ARIPIPRAZOLE5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
ALUMINUM OXIDE(UNII: LMI26O6933)
ALUMINUM(UNII: CPD4NFA903)
CUPROUS CHLORIDE(UNII: C955P95064)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
GOLD(UNII: 79Y1949PYO)
MAGNESIUM(UNII: I38ZP9992A)
SILICON(UNII: Z4152N8IUI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM(UNII: D1JT611TNE)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color BLUE (pale blue) Score no score
Shape RECTANGLE (modified rectangle) Size 8 mm
Flavor Imprint Code DA;030;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-030-851 in 1 KIT 31/01/2018
1NDC:59148-030-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2NDC:59148-030-901 in 1 KIT 31/01/2018
2NDC:59148-030-077 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
3NDC:59148-030-611 in 1 KIT 19/12/2020
3NDC:59148-030-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
4NDC:59148-030-721 in 1 KIT 19/12/2020
4NDC:59148-030-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207202 01/31/2018
Abilify MyCiteARIPIPRAZOLE TABLET WITH SENSOR
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-031
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78)
ARIPIPRAZOLE10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
ALUMINUM OXIDE(UNII: LMI26O6933)
ALUMINUM(UNII: CPD4NFA903)
CUPROUS CHLORIDE(UNII: C955P95064)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
GOLD(UNII: 79Y1949PYO)
MAGNESIUM(UNII: I38ZP9992A)
SILICON(UNII: Z4152N8IUI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM(UNII: D1JT611TNE)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color WHITE (off-white to pale pink) Score no score
Shape RECTANGLE (modified rectangle) Size 8 mm
Flavor Imprint Code DA;031;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-031-851 in 1 KIT 31/01/2018
1NDC:59148-031-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2NDC:59148-031-901 in 1 KIT 31/01/2018
2NDC:59148-031-077 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
3NDC:59148-031-611 in 1 KIT 19/12/2020
3NDC:59148-031-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
4NDC:59148-031-721 in 1 KIT 19/12/2020
4NDC:59148-031-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207202 01/31/2018
Abilify MyCiteARIPIPRAZOLE TABLET WITH SENSOR
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-032
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78)
ARIPIPRAZOLE15 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
ALUMINUM OXIDE(UNII: LMI26O6933)
ALUMINUM(UNII: CPD4NFA903)
CUPROUS CHLORIDE(UNII: C955P95064)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
GOLD(UNII: 79Y1949PYO)
MAGNESIUM(UNII: I38ZP9992A)
SILICON(UNII: Z4152N8IUI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM(UNII: D1JT611TNE)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color YELLOW (pale yellow) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code DA;032;15
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-032-851 in 1 KIT 31/01/2018
1NDC:59148-032-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2NDC:59148-032-901 in 1 KIT 31/01/2018
2NDC:59148-032-077 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
3NDC:59148-032-611 in 1 KIT 19/12/2020
3NDC:59148-032-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
4NDC:59148-032-721 in 1 KIT 19/12/2020
4NDC:59148-032-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207202 01/31/2018
Abilify MyCiteARIPIPRAZOLE TABLET WITH SENSOR
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-033
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78)
ARIPIPRAZOLE20 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
ALUMINUM OXIDE(UNII: LMI26O6933)
ALUMINUM(UNII: CPD4NFA903)
CUPROUS CHLORIDE(UNII: C955P95064)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
GOLD(UNII: 79Y1949PYO)
MAGNESIUM(UNII: I38ZP9992A)
SILICON(UNII: Z4152N8IUI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM(UNII: D1JT611TNE)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color WHITE (white to pale yellowish white) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code DA;033;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-033-851 in 1 KIT 31/01/2018
1NDC:59148-033-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2NDC:59148-033-901 in 1 KIT 31/01/2018
2NDC:59148-033-077 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
3NDC:59148-033-611 in 1 KIT 19/12/2020
3NDC:59148-033-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
4NDC:59148-033-721 in 1 KIT 19/12/2020
4NDC:59148-033-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207202 01/31/2018
Abilify MyCiteARIPIPRAZOLE TABLET WITH SENSOR
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59148-034
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78)
ARIPIPRAZOLE30 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
ALUMINUM OXIDE(UNII: LMI26O6933)
ALUMINUM(UNII: CPD4NFA903)
CUPROUS CHLORIDE(UNII: C955P95064)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
GOLD(UNII: 79Y1949PYO)
MAGNESIUM(UNII: I38ZP9992A)
SILICON(UNII: Z4152N8IUI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM(UNII: D1JT611TNE)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color WHITE (off-white to pale pink) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code DA;034;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59148-034-851 in 1 KIT 31/01/2018
1NDC:59148-034-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2NDC:59148-034-901 in 1 KIT 31/01/2018
2NDC:59148-034-077 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
3NDC:59148-034-611 in 1 KIT 19/12/2020
3NDC:59148-034-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
4NDC:59148-034-721 in 1 KIT 19/12/2020
4NDC:59148-034-1330 in 1 BOTTLE Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207202 01/31/2018

LABELER - Otsuka America Pharmaceutical, Inc.(008314390)

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-029-61

New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)
30-Day Starter Kit

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

2 mg

PRINCIPAL DISPLAY PANEL - Starter Kit Carton - 2 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-029-72

For
New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)

Maintenance Kit (tablets with sensor & strips)

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

2 mg

PRINCIPAL DISPLAY PANEL - Maintenance Kit Carton - 2 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-030-61

New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)
30-Day Starter Kit

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

5 mg

PRINCIPAL DISPLAY PANEL - Starter Kit Carton - 5 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-030-72

For
New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)

Maintenance Kit (tablets with sensor & strips)

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

5 mg

PRINCIPAL DISPLAY PANEL - Maintenance Kit Carton - 5 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-031-61

New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)
30-Day Starter Kit

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

10 mg

PRINCIPAL DISPLAY PANEL - Starter Kit Carton - 10 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-031-72

For
New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)

Maintenance Kit (tablets with sensor & strips)

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

10 mg

PRINCIPAL DISPLAY PANEL - Maintenance Kit Carton - 10 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-032-61

New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)
30-Day Starter Kit

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

15 mg

PRINCIPAL DISPLAY PANEL - Starter Kit Carton - 15 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-032-72

For
New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)

Maintenance Kit (tablets with sensor & strips)

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

15 mg

PRINCIPAL DISPLAY PANEL - Maintenance Kit Carton - 15 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-033-61

New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)
30-Day Starter Kit

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

20 mg

PRINCIPAL DISPLAY PANEL - Starter Kit Carton - 20 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-033-72

For
New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)

Maintenance Kit (tablets with sensor & strips)

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

20 mg

PRINCIPAL DISPLAY PANEL - Maintenance Kit Carton - 20 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-034-61

New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)
30-Day Starter Kit

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

30 mg

PRINCIPAL DISPLAY PANEL - Starter Kit Carton - 30 mg

PRINCIPAL DISPLAY PANEL

30 tablets
Rx only
NDC 59148-034-72

For
New 2-Component
Patch Design

Abilify MyCite®
(aripiprazole tablets with sensor)

Maintenance Kit (tablets with sensor & strips)

Dispense the accompanying Medication Guide to each patient.

Needs a compatible mobile device.
Keep Abilify MyCite® components out of the reach of children. Swallow tablets whole. Do not divide, crush or chew.

30 mg

PRINCIPAL DISPLAY PANEL - Maintenance Kit Carton - 30 mg