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

43aa2a4f-1123-4f86-800b-9218882f7bcd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 27, 2023

Manufacturers

FDA

Solco Healthcare US, LLC

DUNS: 828343017

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Risperidone

PRODUCT DETAILS

NDC Product Code43547-342

Application NumberANDA077493

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJuly 27, 2023

Generic NameRisperidone

INGREDIENTS (13)

CALCIUM SULFATE, UNSPECIFIED FORMInactive

Code: WAT0DDB505

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

RisperidoneActive

Quantity: 2 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

Risperidone

PRODUCT DETAILS

NDC Product Code43547-343

Application NumberANDA077493

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJuly 27, 2023

Generic NameRisperidone

INGREDIENTS (12)

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

RisperidoneActive

Quantity: 3 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Risperidone

PRODUCT DETAILS

NDC Product Code43547-344

Application NumberANDA077493

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJuly 27, 2023

Generic NameRisperidone

INGREDIENTS (11)

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

RisperidoneActive

Quantity: 4 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

Risperidone

PRODUCT DETAILS

NDC Product Code43547-340

Application NumberANDA077493

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJuly 27, 2023

Generic NameRisperidone

INGREDIENTS (12)

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

RisperidoneActive

Quantity: 0.5 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

Risperidone

PRODUCT DETAILS

NDC Product Code43547-339

Application NumberANDA077493

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJuly 27, 2023

Generic NameRisperidone

INGREDIENTS (12)

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

RisperidoneActive

Quantity: 0.25 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Risperidone

PRODUCT DETAILS

NDC Product Code43547-341

Application NumberANDA077493

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateJuly 27, 2023

Generic NameRisperidone

INGREDIENTS (11)

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

RisperidoneActive

Quantity: 1 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

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Risperidone

Products 6

Risperidone

PRODUCT DETAILS

INGREDIENTS (13)

Risperidone

PRODUCT DETAILS

INGREDIENTS (12)

Risperidone

PRODUCT DETAILS

INGREDIENTS (11)

Risperidone

PRODUCT DETAILS

INGREDIENTS (12)

Risperidone

PRODUCT DETAILS

INGREDIENTS (12)

Risperidone

PRODUCT DETAILS

INGREDIENTS (11)

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