donepezil hydrochloride tablet film coated
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 hydrochloride 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 )
sun pharmaceutical industries, inc.
ROUND WHITE 445
445 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1.
DONEPEZIL HYDROCHLORIDE Tablets
DONEPEZIL HYDROCHLORIDE tablets are supplied as film-coated, round tablets containing 5 mg, 10 mg, or 23 mg of
DONEPEZIL HYDROCHLORIDE, USP. The 5 mg tablets are white, biconvex, debossed with ‘440’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap…..................NDC 62756-440-83 Bottles of 90’s with Child Resistant Cap…..................NDC 62756-440-81 Bottles of 100’s with Child Resistant Cap…................NDC 62756-440-88 Bottles of 100’s with Non Child Resistant Cap…........NDC 62756-440-08 Bottles of 1000’s with Non Child Resistant Cap…......NDC 62756-440-18 Unit-Dose blister pack of 30 (3 x 10) tablets………....NDC 62756-440-64 Unit-Dose blister pack of 100 (10 x 10) tablets………NDC 62756-440-65 The 10 mg tablets are yellow, biconvex, debossed with ‘445’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap…..................NDC 62756-445-83 Bottles of 90’s with Child Resistant Cap…..................NDC 62756-445-81 Bottles of 100’s with Child Resistant Cap…................NDC 62756-445-88 Bottles of 100’s with Non Child Resistant Cap…........NDC 62756-445-08 Bottles of 1000’s with Non Child Resistant Cap…......NDC 62756-445-18 Unit-Dose blister pack of 30 (3 x 10) tablets………....NDC 62756-445-64 Unit-Dose blister pack of 100 (10 x 10) tablets………NDC 62756-445-65 The 23 mg tablets are peach, biconvex, debossed with ‘194’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap…..................NDC 62756-194-83 Bottles of 90’s with Child Resistant Cap…..................NDC 62756-194-81 Bottles of 1000’s with Non Child Resistant Cap…......NDC 62756-194-18 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in tight containers (USP).
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