Risperidone
These highlights do not include all the information needed to use Risperidone tablets USP safely and effectively. See full prescribing information for Risperidone tablets USP. Risperidone Tablets USP, for oral useInitial U.S. Approval: 1993
Approved
Approval ID
f06a91eb-5aa0-4722-8644-c56bbd975f02
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2014
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 2
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 Code53808-0909
Application NumberANDA078707
Product Classification
M
Marketing Category
C73584
G
Generic Name
risperidone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2014
FDA Product Classification
INGREDIENTS (14)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
RISPERIDONEActive
Quantity: 2 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-1048
Application NumberANDA078707
Product Classification
M
Marketing Category
C73584
G
Generic Name
risperidone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2014
FDA Product Classification
INGREDIENTS (13)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
RISPERIDONEActive
Quantity: 3 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT