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
d1d8b51c-823b-4702-a726-a7530abd8957
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 27, 2023
Manufacturers
FDA
Exelan Pharmaceuticals Inc.
DUNS: 967795266
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 Code76282-545
Application NumberANDA208200
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vilazodone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2023
FDA Product Classification
INGREDIENTS (11)
VILAZODONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
Vilazodone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-546
Application NumberANDA208200
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vilazodone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2023
FDA Product Classification
INGREDIENTS (12)
VILAZODONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Vilazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-544
Application NumberANDA208200
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vilazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2023
FDA Product Classification
INGREDIENTS (12)
VILAZODONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT