Risperidone
These highlights do not include all the information needed to use risperidone tablets USP safely and effectively. See full prescribing information for risperidone tablets USP.RISPERIDONE tablets USP for oral useInitial U.S. Approval: 1993
Approved
Approval ID
82effea8-5782-4aa5-969e-b635423ae3c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-644
Application NumberANDA076228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2008
FDA Product Classification
INGREDIENTS (12)
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RISPERIDONEActive
Quantity: 3 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-641
Application NumberANDA076228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2008
FDA Product Classification
INGREDIENTS (13)
RISPERIDONEActive
Quantity: 0.5 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-642
Application NumberANDA076228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2008
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
RISPERIDONEActive
Quantity: 1 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-645
Application NumberANDA076228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2008
FDA Product Classification
INGREDIENTS (15)
RISPERIDONEActive
Quantity: 4 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-643
Application NumberANDA076228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2008
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
RISPERIDONEActive
Quantity: 2 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-640
Application NumberANDA076228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2008
FDA Product Classification
INGREDIENTS (13)
RISPERIDONEActive
Quantity: 0.25 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT