risperidone
These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral useInitial U.S. Approval: 1993
Approved
Approval ID
d5abd75f-7f4a-4a7d-b849-82fce88f5ff7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 29, 2023
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-7365
Application NumberANDA078040
Product Classification
M
Marketing Category
C73584
G
Generic Name
risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2023
FDA Product Classification
INGREDIENTS (14)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
RISPERIDONEActive
Quantity: 4 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7364
Application NumberANDA078040
Product Classification
M
Marketing Category
C73584
G
Generic Name
risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2023
FDA Product Classification
INGREDIENTS (11)
RISPERIDONEActive
Quantity: 3 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7361
Application NumberANDA078040
Product Classification
M
Marketing Category
C73584
G
Generic Name
risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2023
FDA Product Classification
INGREDIENTS (10)
RISPERIDONEActive
Quantity: 0.5 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7363
Application NumberANDA078040
Product Classification
M
Marketing Category
C73584
G
Generic Name
risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2023
FDA Product Classification
INGREDIENTS (11)
RISPERIDONEActive
Quantity: 2 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7362
Application NumberANDA078040
Product Classification
M
Marketing Category
C73584
G
Generic Name
risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2023
FDA Product Classification
INGREDIENTS (9)
RISPERIDONEActive
Quantity: 1 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7360
Application NumberANDA078040
Product Classification
M
Marketing Category
C73584
G
Generic Name
risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2023
FDA Product Classification
INGREDIENTS (11)
RISPERIDONEActive
Quantity: 0.25 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT