Donepezil hydrochloride 10 mg
1 INDICATIONS AND USAGE Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s Disease (1) .
Aurobindo Pharma Limited
ROUND YELLOW X 12
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1
DONEPEZIL HYDROCHLORIDE Tablets USP Supplied as film-coated, round tablets containing 5 mg, and 10 mg of
DONEPEZIL HYDROCHLORIDE.
DONEPEZIL HYDROCHLORIDE Tablets USP, 5 mg are white to off-white, circular, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘11’ on the other side. Bottles of 30 NDC 65862-325-30 Bottles of 90 NDC 65862-325-90 Bottles of 100 NDC 65862-325-01 Bottles of 500 NDC 65862-325-05 Bottles of 1,000 NDC 65862-325-99 10 x 10 Unit-dose Tablets NDC 65862-325-10
DONEPEZIL HYDROCHLORIDE Tablets USP, 10 mg are yellow colored, circular, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘12’ on the other side. Bottles of 30 NDC 65862-326-30 Bottles of 90 NDC 65862-326-90 Bottles of 100 NDC 65862-326-01 Bottles of 500 NDC 65862-326-05 Bottles of 1,000 NDC 65862-326-99 10 x 14 Unit-dose Tablets NDC 65862-326-14 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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