MedPath

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

NDC Product Code76282-545
Application NumberANDA208200
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 27, 2023
Generic NameVilazodone hydrochloride

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

NDC Product Code76282-546
Application NumberANDA208200
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 27, 2023
Generic NameVilazodone hydrochloride

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

NDC Product Code76282-544
Application NumberANDA208200
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 27, 2023
Generic NameVilazodone Hydrochloride

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

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