Vilazodone Hydrochloride
These highlights do not include all the information needed to use VILAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for VILAZODONE HYDROCHLORIDE TABLETS. VILAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
3a4745a0-de23-4b40-923e-0d7dfe6b8634
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2022
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
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 Code0480-2045
Application NumberANDA208212
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vilazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification
INGREDIENTS (11)
VILAZODONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Vilazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-2044
Application NumberANDA208212
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vilazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification
INGREDIENTS (12)
VILAZODONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Vilazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-2043
Application NumberANDA208212
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vilazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification
INGREDIENTS (11)
VILAZODONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT