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, for oral use Initial U.S. Approval: 1993
Approved
Approval ID
739dcf8a-ed73-5eb0-899b-7e51cb73c335
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2023
Manufacturers
FDA
Jubilant Cadista Pharmaceuticals Inc.
DUNS: 022490515
Products 5
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 Code59746-010
Application NumberANDA090839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2023
FDA Product Classification
INGREDIENTS (14)
RisperidoneActive
Quantity: 0.5 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
Magnesium Aluminometasilicate Type I-aInactive
Code: 7LVU907546
Classification: IACT
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerInactive
Code: 905HNO1SIH
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Acesulfame PotassiumInactive
Code: 23OV73Q5G9
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-020
Application NumberANDA090839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2023
FDA Product Classification
INGREDIENTS (13)
Magnesium Aluminometasilicate Type I-aInactive
Code: 7LVU907546
Classification: IACT
RisperidoneActive
Quantity: 1 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerInactive
Code: 905HNO1SIH
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Acesulfame PotassiumInactive
Code: 23OV73Q5G9
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-040
Application NumberANDA090839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2023
FDA Product Classification
INGREDIENTS (14)
Magnesium Aluminometasilicate Type I-aInactive
Code: 7LVU907546
Classification: IACT
RisperidoneActive
Quantity: 3 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerInactive
Code: 905HNO1SIH
Classification: IACT
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Acesulfame PotassiumInactive
Code: 23OV73Q5G9
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Fd&c Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-050
Application NumberANDA090839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2023
FDA Product Classification
INGREDIENTS (14)
RisperidoneActive
Quantity: 4 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
Magnesium Aluminometasilicate Type I-aInactive
Code: 7LVU907546
Classification: IACT
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerInactive
Code: 905HNO1SIH
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT
Acesulfame PotassiumInactive
Code: 23OV73Q5G9
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-030
Application NumberANDA090839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2023
FDA Product Classification
INGREDIENTS (14)
Magnesium Aluminometasilicate Type I-aInactive
Code: 7LVU907546
Classification: IACT
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
RisperidoneActive
Quantity: 2 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerInactive
Code: 905HNO1SIH
Classification: IACT
Acesulfame PotassiumInactive
Code: 23OV73Q5G9
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Fd&c Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT