Risperidone
risperiDONE Tablets, USP Rx only These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. Initial U.S. Approval: 1993
Approved
Approval ID
2f9ea0cc-b86b-a11f-e063-6294a90a9620
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 19, 2025
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 3
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 Code42291-976
Application NumberANDA078707
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2025
FDA Product Classification
INGREDIENTS (17)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
RISPERIDONEActive
Quantity: 1 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-975
Application NumberANDA078707
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2025
FDA Product Classification
INGREDIENTS (15)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
RISPERIDONEActive
Quantity: 0.5 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-974
Application NumberANDA078707
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2025
FDA Product Classification
INGREDIENTS (16)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
RISPERIDONEActive
Quantity: 0.25 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT