Donepezil Hydrochloride (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

5 mg label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

10 mg label
(click image for full-size original)
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-646(NDC:0781-5274)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DONEPEZIL HYDROCHLORIDE (DONEPEZIL) DONEPEZIL HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
LECITHIN, SOYBEAN
Product Characteristics
Color WHITE Score no score
Shape ROUND (Film-coated) Size 7mm
Flavor Imprint Code SZ;135
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-646-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-646-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090290 05/31/2011
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-678(NDC:0781-5275)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DONEPEZIL HYDROCHLORIDE (DONEPEZIL) DONEPEZIL HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
LECITHIN, SOYBEAN
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape ROUND (Film-coated) Size 9mm
Flavor Imprint Code SZ;136
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-678-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-678-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090290 05/31/2011
Labeler — McKesson Packaging Services a business unit of McKesson Corporation (140529962)
Establishment
Name Address ID/FEI Operations
McKesson Packaging Services a business unit of McKesson Corporation 140529962 REPACK (63739-646), REPACK (63739-678)

Revised: 02/2015 McKesson Packaging Services a business unit of McKesson Corporation

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