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 Initial U.S. Approval: 2006
Approved
Approval ID
9089db76-aa50-417d-bf62-3674df161e9a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2023
Manufacturers
FDA
Patriot Pharmaceuticals, LLC
DUNS: 178220385
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 Code10147-0952
Application NumberNDA021999
Product Classification
M
Marketing Category
C73605
G
Generic Name
paliperidone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (14)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PALIPERIDONEActive
Quantity: 3 mg in 1 1
Code: 838F01T721
Classification: ACTIB
paliperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10147-0953
Application NumberNDA021999
Product Classification
M
Marketing Category
C73605
G
Generic Name
paliperidone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (12)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PALIPERIDONEActive
Quantity: 6 mg in 1 1
Code: 838F01T721
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
paliperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10147-0951
Application NumberNDA021999
Product Classification
M
Marketing Category
C73605
G
Generic Name
paliperidone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (12)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PALIPERIDONEActive
Quantity: 1.5 mg in 1 1
Code: 838F01T721
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
paliperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10147-0954
Application NumberNDA021999
Product Classification
M
Marketing Category
C73605
G
Generic Name
paliperidone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (12)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PALIPERIDONEActive
Quantity: 9 mg in 1 1
Code: 838F01T721
Classification: ACTIB