MedPath
FDA Product

Risperidone

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Risperidone

53808-0876

Regulatory Information

53808-0876

ANDA076288

C73584

September 30, 2013

USA

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 USP, for oral useInitial U.S. Approval: 1993

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

829348114

Active Ingredients

RISPERIDONE

Quantity: 0.5 mg in 1 1

Code: L6UH7ZF8HC

Class Code: ACTIB

COLLOIDAL SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

DOCUSATE SODIUM

Code: F05Q2T2JA0

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYDEXTROSE

Code: VH2XOU12IE

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

POLYETHYLENE GLYCOLS

Code: 3WJQ0SDW1A

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

Active Moieties

RISPERIDONE

Code: L6UH7ZF8HC

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