NDC Code(s) : 62856-245-30, 62856-245-90, 62856-245-41, 62856-245-11, 62856-246-11, 62856-246-30, 62856-246-90, 62856-246-41, 62856-247-30, 62856-831-30, 62856-832-30
Packager : Eisai Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ariceptdonepezil 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(UNII: 3O2T2PJ89D)
(DONEPEZIL - UNII:8SSC91326P) 		DONEPEZIL HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
Product Characteristics
Color white (WHITE) Score no score
Shape ROUND (ROUND) Size 9 mm
Flavor Imprint Code 5;ARICEPT
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-245-3030 in 1 BOTTLE Type 0: Not a Combination Product25/11/1996
2NDC:62856-245-9090 in 1 BOTTLE Type 0: Not a Combination Product25/11/1996
3NDC:62856-245-4110 in 1 CARTON 25/11/1996
310 in 1 BLISTER PACK Type 0: Not a Combination Product25/11/1996
4NDC:62856-245-111000 in 1 BOTTLE Type 0: Not a Combination Product25/11/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020690 11/25/1996
Ariceptdonepezil 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(UNII: 3O2T2PJ89D)
(DONEPEZIL - UNII:8SSC91326P) 		DONEPEZIL HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
Product Characteristics
Color yellow (YELLOW) Score no score
Shape ROUND (ROUND) Size 9 mm
Flavor Imprint Code 10;ARICEPT
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-246-111000 in 1 BOTTLE Type 0: Not a Combination Product25/11/1996
2NDC:62856-246-3030 in 1 BOTTLE Type 0: Not a Combination Product25/11/1996
3NDC:62856-246-9090 in 1 BOTTLE Type 0: Not a Combination Product25/11/1996
4NDC:62856-246-4110 in 1 CARTON 25/11/1996
410 in 1 BLISTER PACK Type 0: Not a Combination Product25/11/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020690 11/25/1996
Ariceptdonepezil 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(UNII: 3O2T2PJ89D)
(DONEPEZIL - UNII:8SSC91326P) 		DONEPEZIL HYDROCHLORIDE23 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
Product Characteristics
Color red (RED) Score no score
Shape ROUND (ROUND) Size 4 mm
Flavor Imprint Code 23;ARICEPT
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-247-3030 in 1 BOTTLE Type 0: Not a Combination Product23/07/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022568 07/23/2010
Aricept 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(UNII: 3O2T2PJ89D)
(DONEPEZIL - UNII:8SSC91326P) 		DONEPEZIL HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
CARRAGEENAN(UNII: 5C69YCD2YJ)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
Product Characteristics
Color white (White) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 5;ARICEPT
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-831-303 in 1 CARTON 18/10/2004
110 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021720 10/18/2004 04/30/2015
Aricept 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(UNII: 3O2T2PJ89D)
(DONEPEZIL - UNII:8SSC91326P) 		DONEPEZIL HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
CARRAGEENAN(UNII: 5C69YCD2YJ)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow (yellow) Score no score
Shape ROUND (Round) Size 9 mm
Flavor Imprint Code 10;ARICEPT
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-832-303 in 1 CARTON 18/10/2004
110 in 1 BLISTER PACK Type 0: Not a Combination Product
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 Business Operations
Catalent Pharma Solutions, LLC 014167995 analysis(62856-245, 62856-246, 62856-247, 62856-831, 62856-832)

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

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

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

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

PRINCIPAL DISPLAY PANEL

PRIN CIPAL DISPLAY PANEL - ARICEPT 5 MG TABLETS

NDC 62856-245-30

Aricept® 
donepezil HCl tablet

5 mg
30 Tablets

NDC 62856-245-30 Aricept® donepezil HCl tablet 5 mg 30 Tablets

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - ARICEPT 10 MG TABLETS

NDC 62856-246-30

Aricept®
donepezil HCl tablet

10 mg
30 Tablets

NDC 62856-246-30 Aricept® donepezil HCl tablet 10 mg 30 Tablets

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - ARICEPT 23 MG TABLETS

NDC 62856-247-30

Aricept®
donepezil HCl tablet

23 mg
30 tablets

NDC 62856-247-30 Aricept® donepezil HCl tablet 23 mg 30 tablets

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - ARICEPT ODT 5 MG TABLETS

NDC 62856-831-30

ARICEPT® ODT™
(donepezil HCl) 5 MG
orally disintegrating tablets

NDC 62856-831-30 ARICEPT® ODT™ (donepezil HCl) 5 MG orally disintegrating tablets

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - ARICEPT ODT 10 MG TABLETS

NDC 62856-832-30

ARICEPT® ODT™
(donepezil HCl) 10 MG
orally disintegrating tablets

NDC 62856-832-30 ARICEPT® ODT™ (donepezil HCl) 10 MG orally disintegrating tablets