Application 022568

Type: NDA
Sponsor: EISAI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARICEPT	DONEPEZIL HYDROCHLORIDE	TABLET;ORAL	23MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022568-001	ARICEPT	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022568-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022568-001	8481565	2026-10-04		Drug product	2013-07-09

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022568-001	ARICEPT	23MG	TABLET / ORAL	AB	RLD, RS	2010-07-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022568-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022568-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022568-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022568-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022568-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022568-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022568-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022568-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022568-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022568-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022568-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022568-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022568-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022568-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022568-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022568-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022568-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022568-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022568-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022568-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022568-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022568-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022568-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022568-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022568-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022568-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022568-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022568-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022568-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022568-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022568-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022568-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022568-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022568-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022568-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022568-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022568-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022568-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022568-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022568-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022568-001	8481565	2026-10-04	Drug product	2013-07-09	`cb3db0bc1861…`

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 application applno (NDA): 022568 application number: NDA022568 ndc (product): 62856-247

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
62856-247	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-247	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-247	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-247	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-247	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-247	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-247	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current
62856-247	Aricept	donepezil hydrochloride	Eisai Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56790	SUPPL	2018-12-19
38847	SUPPL	2015-07-22
7544	SUPPL	2015-07-22
7543	SUPPL	2013-09-10
38846	SUPPL	2013-09-09
17719	SUPPL	2012-09-26
29867	SUPPL	2012-09-06
38845	SUPPL	2012-03-09
7542	SUPPL	2012-03-05
24343	ORIG	2011-02-17
42559	ORIG	2010-12-01
38844	SUPPL	2010-12-01
29866	SUPPL	2010-11-30
38843	ORIG	2010-07-30
7541	ORIG	2010-07-28