Donepezil (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10 mg

Donepezil Hydrochloride Tablets, USP 10 mg — 30s count

Donepezil10mg30s
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Donepezil Hydrochloride Tablets, USP 10 mg — Blister carton

Donepezil10mgcarton
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Donepezil Hydrochloride Tablets, USP 10 mg — Blister foil

Donepezil10mgfoil
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DONEPEZIL donepezil hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-737
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
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
HYDROXYPROPYL CELLULOSE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;24
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-737-30 30 TABLET in 1 BOTTLE None
2 NDC:31722-737-90 90 TABLET in 1 BOTTLE None
3 NDC:31722-737-01 100 TABLET in 1 BOTTLE None
4 NDC:31722-737-05 500 TABLET in 1 BOTTLE None
5 NDC:31722-737-31 100 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203034 02/02/2015
DONEPEZIL donepezil hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-738
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
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 9mm
Flavor Imprint Code I;21
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-738-30 30 TABLET in 1 BOTTLE None
2 NDC:31722-738-90 90 TABLET in 1 BOTTLE None
3 NDC:31722-738-01 100 TABLET in 1 BOTTLE None
4 NDC:31722-738-05 500 TABLET in 1 BOTTLE None
5 NDC:31722-738-31 100 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203034 02/02/2015
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit V 650452530 ANALYSIS (31722-737), ANALYSIS (31722-738), MANUFACTURE (31722-737), MANUFACTURE (31722-738)

Revised: 12/2019 Camber Pharmaceuticals, Inc.

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