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
9c2593ed-4551-4921-a82e-24a727712113
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 25, 2019
Manufacturers
FDA
Inventia Healthcare Limited
DUNS: 677604412
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PALIPERIDONE
PRODUCT DETAILS
NDC Product Code49252-034
Application NumberANDA204452
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 25, 2019
Generic NamePALIPERIDONE
INGREDIENTS (14)
PALIPERIDONEActive
Quantity: 6 mg in 1 1
Code: 838F01T721
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PALIPERIDONE
PRODUCT DETAILS
NDC Product Code49252-033
Application NumberANDA204452
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 25, 2019
Generic NamePALIPERIDONE
INGREDIENTS (12)
PALIPERIDONEActive
Quantity: 3 mg in 1 1
Code: 838F01T721
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PALIPERIDONE
PRODUCT DETAILS
NDC Product Code49252-035
Application NumberANDA204452
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 25, 2019
Generic NamePALIPERIDONE
INGREDIENTS (13)
PALIPERIDONEActive
Quantity: 9 mg in 1 1
Code: 838F01T721
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PALIPERIDONE
PRODUCT DETAILS
NDC Product Code49252-032
Application NumberANDA204452
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 25, 2019
Generic NamePALIPERIDONE
INGREDIENTS (14)
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
PALIPERIDONEActive
Quantity: 1.5 mg in 1 1
Code: 838F01T721
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT