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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

f917f30d-f2a7-43eb-836f-53eaa2a31cb0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 13, 2023

Manufacturers
FDA

Accord Healthcare Inc.

DUNS: 604222237

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 Code16729-354
Application NumberANDA208209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vilazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2023
FDA Product Classification

INGREDIENTS (9)

VILAZODONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

Vilazodone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16729-352
Application NumberANDA208209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vilazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2023
FDA Product Classification

INGREDIENTS (9)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
VILAZODONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB

Vilazodone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16729-353
Application NumberANDA208209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vilazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2023
FDA Product Classification

INGREDIENTS (9)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VILAZODONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: U8HTX2GK8J
Classification: ACTIB

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Vilazodone Hydrochloride - FDA Drug Approval Details