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FDA Drug information

Venlafaxine hydrochloride

Read time: 1 mins
Marketing start date: 23 Dec 2024

Summary of product characteristics


Effective Time

20230928

Version

10

Spl Product Data Elements

venlafaxine hydrochloride venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE VENLAFAXINE FERROSOFERRIC OXIDE HYPROMELLOSES GELATIN SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE CETOSTEARYL ALCOHOL SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) GRAY WHITE CAPSULE ZA;35;37;5;mg venlafaxine hydrochloride venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE VENLAFAXINE FERROSOFERRIC OXIDE HYPROMELLOSES GELATIN SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE CETOSTEARYL ALCOHOL FERRIC OXIDE RED SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) PEACH WHITE CAPSULE ZA;36;75;mg venlafaxine hydrochloride venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE VENLAFAXINE FERROSOFERRIC OXIDE HYPROMELLOSES GELATIN SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE CETOSTEARYL ALCOHOL FERRIC OXIDE RED SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) DARK ORANGE WHITE CAPSULE ZA;37;150;mg

Application Number

ANDA090174

Brand Name

Venlafaxine hydrochloride

Generic Name

venlafaxine hydrochloride

Product Ndc

65841-753

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-751-10 Venlafaxine Hydrochloride Extended-release Capsules USP, 37.5 mg 1000 Capsules Rx only NDC 65841-752-10 Venlafaxine Hydrochloride Extended-release Capsules USP, 75 mg 1000 Capsules Rx only NDC 65841-753-10 Venlafaxine Hydrochloride Extended-release Capsules USP, 150 mg 1000 Capsules Rx only Venlafaxine hydrochloride extended-release capsules, USP Venlafaxine hydrochloride extended-release capsules, USP Venlafaxine hydrochloride extended-release capsules, USP

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