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 use Initial U.S. Approval: 2006

Approved

Approval ID

e713556e-028e-0f4c-e053-2995a90a9e9f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 28, 2023

Manufacturers

FDA

Archis Pharma LLC

DUNS: 026836212

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 Code72819-159

Application NumberANDA203802

Product Classification

Marketing Category

C73584

Generic Name

paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 28, 2023

FDA Product Classification

INGREDIENTS (17)

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

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

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

paliperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72819-157

Application NumberANDA203802

Product Classification

Marketing Category

C73584

Generic Name

paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 28, 2023

FDA Product Classification

INGREDIENTS (17)

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

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, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

POLYETHYLENE OXIDE 5000000Inactive

Code: 3IG9032SAH

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IE

Classification: IACT

PALIPERIDONEActive

Quantity: 1.5 mg in 1 1

Code: 838F01T721

Classification: ACTIB

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

paliperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72819-160

Application NumberANDA203802

Product Classification

Marketing Category

C73584

Generic Name

paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 28, 2023

FDA Product Classification

INGREDIENTS (17)

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, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

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

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

PALIPERIDONEActive

Quantity: 9 mg in 1 1

Code: 838F01T721

Classification: ACTIB

paliperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72819-158

Application NumberANDA203802

Product Classification

Marketing Category

C73584

Generic Name

paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 28, 2023

FDA Product Classification

INGREDIENTS (16)

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

POLYETHYLENE OXIDE 5000000Inactive

Code: 3IG9032SAH

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

PALIPERIDONEActive

Quantity: 3 mg in 1 1

Code: 838F01T721

Classification: ACTIB

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Paliperidone

Products 4

paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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