Paliperidone

Paliperidone tablet, extended release Rx only 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. Initial U.S. Approval: 2006

Approved

Approval ID

018cf3ca-bee9-23a6-e063-6394a90ad905

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 10, 2023

Manufacturers

FDA

AvKARE

DUNS: 796560394

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 Code42291-916

Application NumberANDA204707

Product Classification

Marketing Category

C73584

Generic Name

Paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2023

FDA Product Classification

INGREDIENTS (14)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FUMARIC ACIDInactive

Code: 88XHZ13131

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL 100000Inactive

Code: V46Y6OJ5QB

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

PALIPERIDONEActive

Quantity: 3 mg in 1 1

Code: 838F01T721

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

Paliperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42291-917

Application NumberANDA204707

Product Classification

Marketing Category

C73584

Generic Name

Paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2023

FDA Product Classification

INGREDIENTS (16)

POLYETHYLENE GLYCOL 100000Inactive

Code: V46Y6OJ5QB

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FUMARIC ACIDInactive

Code: 88XHZ13131

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

PALIPERIDONEActive

Quantity: 6 mg in 1 1

Code: 838F01T721

Classification: ACTIB

Paliperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42291-918

Application NumberANDA204707

Product Classification

Marketing Category

C73584

Generic Name

Paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2023

FDA Product Classification

INGREDIENTS (17)

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

PALIPERIDONEActive

Quantity: 9 mg in 1 1

Code: 838F01T721

Classification: ACTIB

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL 100000Inactive

Code: V46Y6OJ5QB

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

FUMARIC ACIDInactive

Code: 88XHZ13131

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

Paliperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42291-915

Application NumberANDA204707

Product Classification

Marketing Category

C73584

Generic Name

Paliperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 10, 2023

FDA Product Classification

INGREDIENTS (17)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FUMARIC ACIDInactive

Code: 88XHZ13131

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 100000Inactive

Code: V46Y6OJ5QB

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

PALIPERIDONEActive

Quantity: 1.5 mg in 1 1

Code: 838F01T721

Classification: ACTIB

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

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Paliperidone

Products 4

Paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Paliperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

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