Application 021720

Type: NDA
Sponsor: EISAI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARICEPT ODT	DONEPEZIL HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	Yes	No
002	ARICEPT ODT	DONEPEZIL HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021720-001	ARICEPT ODT	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2004-10-18
N021720-002	ARICEPT ODT	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2004-10-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021720-001	ARICEPT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021720-002	ARICEPT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-10-18	`782e0a99824c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aricept	DONEPEZIL HYDROCHLORIDE	Eisai Inc.	98e451e1-e4d7-4439-a675-c5457ba20975	2021-12-30	Warnings, Adverse reactions	Exact identifier ndc (product): 62856-831 ndc (product): 62856-832

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62856-831	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-831	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-831	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-831	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-832	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-832	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-832	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-832	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56931	SUPPL	2018-12-21
56791	SUPPL	2018-12-19
28456	SUPPL	2015-07-22
16255	SUPPL	2015-07-22
6045	SUPPL	2013-09-10
37516	SUPPL	2013-09-09
28454	SUPPL	2013-04-09
16254	SUPPL	2012-09-26
6044	SUPPL	2012-09-06
16253	SUPPL	2012-03-09
28455	SUPPL	2012-03-05
37515	SUPPL	2010-12-01
6043	SUPPL	2010-11-30
37514	SUPPL	2006-10-18
28453	SUPPL	2006-10-18
21788	ORIG	2006-06-08
16252	ORIG	2004-10-22
6042	ORIG	2004-10-22