Aricept (Page 6 of 6)

PRIN CIPAL DISPLAY PANEL — ARICEPT 5 MG TABLETS

NDC 62856-245-30

Aricept®
donepezil HCl tablet

5 mg30 Tablets

NDC 62856-245-30

Aricept® 
donepezil HCl tablet

5 mg
30 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — ARICEPT 10 MG TABLETS

NDC 62856-246-30

Aricept®
donepezil HCl tablet

10 mg30 Tablets

NDC 62856-246-30

Aricept®
donepezil HCl tablet

10 mg
30 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — ARICEPT 23 MG TABLETS

NDC 62856-247-30

Aricept®
donepezil HCl tablet

23 mg30 tablets

NDC 62856-247-30

Aricept®
donepezil HCl tablet

23 mg
30 tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — ARICEPT ODT 5 MG TABLETS

NDC 62856-831-30

ARICEPT® ODT
(donepezil HCl) 5 MGorally disintegrating tablets

NDC 62856-831-30

ARICEPT® ODT™
(donepezil HCl) 5 MG
orally disintegrating tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — ARICEPT ODT 10 MG TABLETS

NDC 62856-832-30

ARICEPT® ODT
(donepezil HCl) 10 MGorally disintegrating tablets

NDC 62856-832-30

ARICEPT® ODT™
(donepezil HCl) 10 MG
orally disintegrating tablets
(click image for full-size original)
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.

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