Venlafaxine Hydrochloride

VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. VENLAFAXINE HYDROCHLORIDE extended-release tablets for oral use Initial U.S. Approval: 1993

Approved

Approval ID

b7f7dda5-95d7-4b58-89af-4fcf57cdec60

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 15, 2023

Manufacturers

FDA

Golden State Medical Supply

DUNS: 603184490

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

venlafaxine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60429-867

Application NumberANDA205468

Product Classification

Marketing Category

C73584

Generic Name

venlafaxine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 15, 2023

FDA Product Classification

INGREDIENTS (13)

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

VENLAFAXINE HYDROCHLORIDEActive

Quantity: 225 mg in 1 1

Code: 7D7RX5A8MO

Classification: ACTIM

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

venlafaxine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60429-866

Application NumberANDA205468

Product Classification

Marketing Category

C73584

Generic Name

venlafaxine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateAugust 15, 2023

FDA Product Classification

INGREDIENTS (13)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

VENLAFAXINE HYDROCHLORIDEActive

Quantity: 150 mg in 1 1

Code: 7D7RX5A8MO

Classification: ACTIM

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Venlafaxine Hydrochloride

Products 2

venlafaxine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

venlafaxine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

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