Risperidone
These highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets Initial U.S. Approval: 1993
Approved
Approval ID
856d65dc-f330-4195-b271-d0bdbe99519d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Natco Pharma USA LLC
DUNS: 079590418
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 Code69339-183
Application NumberANDA091537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (12)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
RISPERIDONEActive
Quantity: 1 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69339-186
Application NumberANDA091537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (14)
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
RISPERIDONEActive
Quantity: 4 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
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 Code69339-184
Application NumberANDA091537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (12)
RISPERIDONEActive
Quantity: 2 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69339-181
Application NumberANDA091537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (12)
RISPERIDONEActive
Quantity: 0.25 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69339-185
Application NumberANDA091537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (14)
RISPERIDONEActive
Quantity: 3 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
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 Code69339-182
Application NumberANDA091537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (12)
RISPERIDONEActive
Quantity: 0.5 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT