Donepezil Hydrochloride 5 Mg (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Donepezil Hydrochloride Tablets, USP 5 mg (30 Tablets in 1 Bottle)
Each film-coated tablet contains 5 mg donepezil hydrochloride USP.46708-092-30

5 mg-30 Tablets in HDPE Bottle Pack
(click image for full-size original)

Donepezil Hydrochloride Tablets, USP 10 mg (30 Tablets in 1 Bottle)
Each film-coated tablet contains 10 mg donepezil hydrochloride USP.46708-093-30

10 mg-30 Tablets in HDPE Bottle Pack
(click image for full-size original)
DONEPEZIL HYDROCHLORIDE 5 MG donepezil hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-092
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
HYDROXYPROPYL CELLULOSE
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
TALC
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (round,biconvex) Size 7mm
Flavor Imprint Code L160
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-092-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-092-91 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-092-10 100 TABLET, FILM COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201724 03/04/2013
DONEPEZIL HYDROCHLORIDE 5 MG donepezil hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-093
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
HYDROXYPROPYL CELLULOSE
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 9mm
Flavor Imprint Code L161
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-093-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-093-91 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-093-10 100 TABLET, FILM COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201724 02/19/2013
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-092), MANUFACTURE (46708-093)

Revised: 05/2014 Alembic Pharmaceuticals Limited

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