Abilify MyCite

These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002

Approved

Approval ID

e8787c3f-5e41-42d1-8091-44b56346620f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 16, 2023

Manufacturers

FDA

Otsuka America Pharmaceutical, Inc.

DUNS: 008314390

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ARIPIPRAZOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59148-030

Application NumberNDA207202

Product Classification

Marketing Category

C73594

Generic Name

ARIPIPRAZOLE

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 24, 2023

FDA Product Classification

INGREDIENTS (19)

ARIPIPRAZOLEActive

Quantity: 5 mg in 1 1

Code: 82VFR53I78

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

CUPROUS CHLORIDEInactive

Code: C955P95064

Classification: IACT

GOLDInactive

Code: 79Y1949PYO

Classification: IACT

ALUMINUMInactive

Code: CPD4NFA903

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

MAGNESIUMInactive

Code: I38ZP9992A

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SILICONInactive

Code: Z4152N8IUI

Classification: IACT

TITANIUMInactive

Code: D1JT611TNE

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

ARIPIPRAZOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59148-032

Application NumberNDA207202

Product Classification

Marketing Category

C73594

Generic Name

ARIPIPRAZOLE

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 24, 2023

FDA Product Classification

INGREDIENTS (19)

ARIPIPRAZOLEActive

Quantity: 15 mg in 1 1

Code: 82VFR53I78

Classification: ACTIB

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

ALUMINUMInactive

Code: CPD4NFA903

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

CUPROUS CHLORIDEInactive

Code: C955P95064

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

SILICONInactive

Code: Z4152N8IUI

Classification: IACT

GOLDInactive

Code: 79Y1949PYO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUMInactive

Code: I38ZP9992A

Classification: IACT

TITANIUMInactive

Code: D1JT611TNE

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

ARIPIPRAZOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59148-031

Application NumberNDA207202

Product Classification

Marketing Category

C73594

Generic Name

ARIPIPRAZOLE

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 24, 2023

FDA Product Classification

INGREDIENTS (19)

ARIPIPRAZOLEActive

Quantity: 10 mg in 1 1

Code: 82VFR53I78

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ALUMINUMInactive

Code: CPD4NFA903

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

GOLDInactive

Code: 79Y1949PYO

Classification: IACT

CUPROUS CHLORIDEInactive

Code: C955P95064

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

MAGNESIUMInactive

Code: I38ZP9992A

Classification: IACT

SILICONInactive

Code: Z4152N8IUI

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUMInactive

Code: D1JT611TNE

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

ARIPIPRAZOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59148-033

Application NumberNDA207202

Product Classification

Marketing Category

C73594

Generic Name

ARIPIPRAZOLE

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 24, 2023

FDA Product Classification

INGREDIENTS (19)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ARIPIPRAZOLEActive

Quantity: 20 mg in 1 1

Code: 82VFR53I78

Classification: ACTIB

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

ALUMINUMInactive

Code: CPD4NFA903

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

CUPROUS CHLORIDEInactive

Code: C955P95064

Classification: IACT

SILICONInactive

Code: Z4152N8IUI

Classification: IACT

MAGNESIUMInactive

Code: I38ZP9992A

Classification: IACT

GOLDInactive

Code: 79Y1949PYO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUMInactive

Code: D1JT611TNE

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

ARIPIPRAZOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59148-034

Application NumberNDA207202

Product Classification

Marketing Category

C73594

Generic Name

ARIPIPRAZOLE

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 24, 2023

FDA Product Classification

INGREDIENTS (19)

ARIPIPRAZOLEActive

Quantity: 30 mg in 1 1

Code: 82VFR53I78

Classification: ACTIB

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

CUPROUS CHLORIDEInactive

Code: C955P95064

Classification: IACT

ALUMINUMInactive

Code: CPD4NFA903

Classification: IACT

GOLDInactive

Code: 79Y1949PYO

Classification: IACT

MAGNESIUMInactive

Code: I38ZP9992A

Classification: IACT

SILICONInactive

Code: Z4152N8IUI

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUMInactive

Code: D1JT611TNE

Classification: IACT

ARIPIPRAZOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59148-029

Application NumberNDA207202

Product Classification

Marketing Category

C73594

Generic Name

ARIPIPRAZOLE

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 24, 2023

FDA Product Classification

INGREDIENTS (19)

ARIPIPRAZOLEActive

Quantity: 2 mg in 1 1

Code: 82VFR53I78

Classification: ACTIB

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ALUMINUMInactive

Code: CPD4NFA903

Classification: IACT

CUPROUS CHLORIDEInactive

Code: C955P95064

Classification: IACT

MAGNESIUMInactive

Code: I38ZP9992A

Classification: IACT

SILICONInactive

Code: Z4152N8IUI

Classification: IACT

TITANIUMInactive

Code: D1JT611TNE

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

GOLDInactive

Code: 79Y1949PYO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

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Abilify MyCite

Products 6

ARIPIPRAZOLE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

ARIPIPRAZOLE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

ARIPIPRAZOLE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

ARIPIPRAZOLE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

ARIPIPRAZOLE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

ARIPIPRAZOLE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

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