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FDA Drug information

Donepezil hydrochloride

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20221105

Version

5

Spl Product Data Elements

donepezil hydrochloride donepezil hydrochloride DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE TALC TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED WHITE TO OFF-WHITE ROUND ZF9 donepezil hydrochloride donepezil hydrochloride DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE STARCH, CORN WHITE TO OFF-WHITE ROUND ZF10

Application Number

ANDA090100

Brand Name

Donepezil hydrochloride

Generic Name

donepezil hydrochloride

Product Ndc

65841-749

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-749-01 in bottle of 100 tablets Donepezil Hydrochloride Tablets USP, 5 mg R x only 100 tablets NDC 65841-750-01 in bottle of 100 tablets Donepezil Hydrochloride Tablets USP, 10 mg R x only 100 tablets Donepezil HCl Tablets, USP Donepezil HCl Tablets, USP

Drug section

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