Aricept (Page 6 of 6)

PRIN CIPAL DISPLAY PANEL — ARICEPT 5 MG TABLETS

NDC 62856-245-30

Aricept^®
donepezil HCl tablet

5 mg30 Tablets

PRINCIPAL DISPLAY PANEL — ARICEPT 10 MG TABLETS

NDC 62856-246-30

Aricept^®
donepezil HCl tablet

10 mg30 Tablets

PRINCIPAL DISPLAY PANEL — ARICEPT 23 MG TABLETS

NDC 62856-247-30

Aricept^®
donepezil HCl tablet

23 mg30 tablets

PRINCIPAL DISPLAY PANEL — ARICEPT ODT 5 MG TABLETS

NDC 62856-831-30

ARICEPT^® ODT^™
(donepezil HCl) 5 MGorally disintegrating tablets

PRINCIPAL DISPLAY PANEL — ARICEPT ODT 10 MG TABLETS

NDC 62856-832-30

ARICEPT^® ODT^™
(donepezil HCl) 10 MGorally disintegrating tablets

ARICEPT donepezil hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-245 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 POLYETHYLENE GLYCOL 8000 HYPROMELLOSES TITANIUM DIOXIDE HYDROXYPROPYL CELLULOSE (90000 WAMW)

Product Characteristics Color white (WHITE) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 5;ARICEPT Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62856-245-30 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:62856-245-90 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:62856-245-41 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (62856-245-41) 4 NDC:62856-245-11 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020690 11/25/1996

ARICEPT donepezil hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-246 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 POLYETHYLENE GLYCOL 8000 HYPROMELLOSES TITANIUM DIOXIDE FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE (90000 WAMW)

Product Characteristics Color yellow (YELLOW) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 10;ARICEPT Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62856-246-11 1000 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:62856-246-30 30 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:62856-246-90 90 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:62856-246-41 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (62856-246-41)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020690 11/25/1996

ARICEPT donepezil hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-247 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DONEPEZIL HYDROCHLORIDE (DONEPEZIL) DONEPEZIL HYDROCHLORIDE 23 mg

Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER FERRIC OXIDE RED HYPROMELLOSE 2910 (3 MPA.S) POLYETHYLENE GLYCOL 8000 TALC TITANIUM DIOXIDE HYDROXYPROPYL CELLULOSE (90000 WAMW)

Product Characteristics Color red (RED) Score no score Shape ROUND (ROUND) Size 4mm Flavor Imprint Code 23;ARICEPT Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62856-247-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022568 07/23/2010

ARICEPT ODT donepezil hydrochloride tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-831 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 CARRAGEENAN MANNITOL SILICON DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED

Product Characteristics Color white (White) Score no score Shape ROUND Size 9mm Flavor Imprint Code 5;ARICEPT Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62856-831-30 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (62856-831-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021720 10/18/2004 04/30/2015

ARICEPT ODT donepezil hydrochloride tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-832 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 CARRAGEENAN MANNITOL SILICON DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED FERRIC OXIDE YELLOW

Product Characteristics Color yellow (yellow) Score no score Shape ROUND (Round) Size 9mm Flavor Imprint Code 10;ARICEPT Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62856-832-30 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (62856-832-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021720 10/18/2004 02/28/2017

Labeler — Eisai Inc. (189246791)

Establishment
Name	Address	ID/FEI	Operations
Catalent Pharma Solutions, LLC		014167995	analysis (62856-245), analysis (62856-246), analysis (62856-247), analysis (62856-831), analysis (62856-832)

Establishment
Name	Address	ID/FEI	Operations
Eisai Co., Ltd.		695153247	analysis (62856-247), manufacture (62856-247)

Establishment
Name	Address	ID/FEI	Operations
Eisai Co., Ltd.		695319983	analysis (62856-245), analysis (62856-246), analysis (62856-247), analysis (62856-831), analysis (62856-832), api manufacture (62856-245), api manufacture (62856-246), api manufacture (62856-247), api manufacture (62856-831), api manufacture (62856-832)

Establishment
Name	Address	ID/FEI	Operations
Eisai Manufacturing Ltd		219516916	analysis (62856-245), analysis (62856-246), manufacture (62856-245), manufacture (62856-246)

Establishment
Name	Address	ID/FEI	Operations
Pharma Packaging Solutions, LLC dba Tjoapack, LLC		928861723	label (62856-245), label (62856-246), label (62856-247), pack (62856-245), pack (62856-246), pack (62856-247)

Revised: 11/2022 Eisai Inc.