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FDA Drug information

Memantine Hydrochloride

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


Effective Time

20221105

Version

6

Spl Product Data Elements

Memantine Hydrochloride Memantine Hydrochloride MEMANTINE HYDROCHLORIDE MEMANTINE SILICON DIOXIDE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POVIDONE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED WHITE TO OFF-WHITE CAPSULE ZF;41 Memantine Hydrochloride Memantine Hydrochloride MEMANTINE HYDROCHLORIDE MEMANTINE SILICON DIOXIDE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POVIDONE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED WHITE TO OFF-WHITE CAPSULE ZF;40

Application Number

ANDA090961

Brand Name

Memantine Hydrochloride

Generic Name

Memantine Hydrochloride

Product Ndc

70771-1119

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1119-1 in bottle of 100 tablets Memantine Hydrochloride Tablets USP, 5 mg Rx only 100 tablets NDC 70771-1120-1 in bottle of 100 tablets Memantine Hydrochloride Tablets USP, 10 mg Rx only 100 tablets Memantine Hydrochloride Tablets Memantine Hydrochloride Tablets

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