Paliperidone

These highlights do not include all the information needed to use PALIPERIDONE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PALIPERIDONE EXTENDED-RELEASE TABLETS. PALIPERIDONE extended-release tablets, for oral useInitial U.S. Approval: 2006

Approved

Approval ID

74702340-19bf-467e-80cd-68dca9d374d2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 14, 2019

Manufacturers

FDA

Mylan Pharmaceuticals Inc.

DUNS: 059295980

Products 4

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

paliperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0378-3980

Application NumberANDA203802

Product Classification

Marketing Category

C73584

Generic Name

paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 14, 2019

FDA Product Classification

INGREDIENTS (22)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

POLYETHYLENE OXIDE 5000000Inactive

Code: 3IG9032SAH

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

PALIPERIDONEActive

Quantity: 6 mg in 1 1

Code: 838F01T721

Classification: ACTIB

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

paliperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0378-3978

Application NumberANDA203802

Product Classification

Marketing Category

C73584

Generic Name

paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 14, 2019

FDA Product Classification

INGREDIENTS (21)

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

PALIPERIDONEActive

Quantity: 1.5 mg in 1 1

Code: 838F01T721

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

POLYETHYLENE OXIDE 5000000Inactive

Code: 3IG9032SAH

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IE

Classification: IACT

paliperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0378-3979

Application NumberANDA203802

Product Classification

Marketing Category

C73584

Generic Name

paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 14, 2019

FDA Product Classification

INGREDIENTS (21)

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

PALIPERIDONEActive

Quantity: 3 mg in 1 1

Code: 838F01T721

Classification: ACTIB

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYETHYLENE OXIDE 5000000Inactive

Code: 3IG9032SAH

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

paliperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0378-3981

Application NumberANDA203802

Product Classification

Marketing Category

C73584

Generic Name

paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 14, 2019

FDA Product Classification

INGREDIENTS (22)

PALIPERIDONEActive

Quantity: 9 mg in 1 1

Code: 838F01T721

Classification: ACTIB

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

POLYETHYLENE OXIDE 5000000Inactive

Code: 3IG9032SAH

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

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Paliperidone

Products 4

paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (22)

paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (22)

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