vilazodone
These highlights do not include all the information needed to use VILAZODONE safely and effectively. See full prescribing information for VILAZODONE . VILAZODONE t ablets , for oral us e Initial U.S. Approval: 201 1
Approved
Approval ID
fad37b72-1ebe-4a71-835d-b0c1e4b90011
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2021
Manufacturers
FDA
Apotex Corp
DUNS: 845263701
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
vilazodone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4774
Application NumberNDA022567
Product Classification
M
Marketing Category
C73605
G
Generic Name
vilazodone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2023
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VILAZODONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
vilazodone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4773
Application NumberNDA022567
Product Classification
M
Marketing Category
C73605
G
Generic Name
vilazodone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2023
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
VILAZODONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
vilazodone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4772
Application NumberNDA022567
Product Classification
M
Marketing Category
C73605
G
Generic Name
vilazodone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2023
FDA Product Classification
INGREDIENTS (10)
VILAZODONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT