Donepezil Hydrochloride

Product NDC: 64239-404
11-digit product format: 642390404
Labeler code: 64239
Product ID: 64239-404_4881001c-c215-2033-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dexcel Pharma Technologies Ltd.
Application: ANDA203713
Marketing category: ANDA
Marketing start: 2016-07-01
Marketing end: 0000-00-00
Substance: DONEPEZIL HYDROCHLORIDE
Active strength: 23 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64239-404		I	Inactivated by FDA	2026-08-03
excluded package	package	64239-404	64239-404-03	I	Inactivated by FDA	2026-08-03
excluded package	package	64239-404	64239-404-10	I	Inactivated by FDA	2026-08-03
excluded package	package	64239-404	64239-404-50	I	Inactivated by FDA	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 88 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64239-404-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64239-404-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64239-404-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64239-404-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64239-404-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64239-404-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64239-404-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64239-404-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64239-404-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64239-404-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64239-404-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64239-404-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64239-404-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64239-404-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64239-404-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64239-404-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64239-404-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64239-404-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64239-404-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64239-404-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64239-404-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64239-404-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64239-404-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64239-404-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64239-404-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64239-404-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64239-404-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64239-404-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64239-404-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64239-404-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64239-404-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64239-404-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64239-404-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64239-404-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64239-404-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64239-404-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64239-404-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64239-404-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64239-404-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64239-404-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64239-404-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64239-404-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64239-404-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64239-404-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64239-404-03	`1332a3947898…`	`d4bfe170f9cd…`

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
A203713-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB		2016-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203713-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`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	A203713-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203713-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203713-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203713-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203713-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203713-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203713-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203713-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203713-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203713-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203713-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203713-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203713-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203713-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203713-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203713-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203713-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203713-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203713-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203713-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203713-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203713-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203713-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203713-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203713-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203713-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203713-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203713-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203713-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203713-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203713-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203713-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203713-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203713-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203713-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203713-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203713-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203713-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203713-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203713-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
94db636e-a074-45fd-8e8d-331920a99436	Product name	4	20250103
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7	Product name	1	20221214
d7e50b51-94ef-29ef-8273-837d555048c1	Product name	9	20160811

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
64239-404-07	2020-02-04	9d75b9d0-e197-f424-e053-dadaa90a57ce	503e10a5-daaf-4e4f-8528-72f299316bbc
64239-404-03	2020-01-31	9d75b9d0-8242-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Donepezil Hydrochloride Tablets safely and effectively. See full prescribing information for Donepezil Hydrochloride Tablets. DONEPEZIL Hydrochloride Tablets, for oral use Initial U.S. Approval: 1996
64239-404-07	2020-01-31	9d75b9d0-e197-f424-e053-dadaa90a57ce	503e10a5-daaf-4e4f-8528-72f299316bbc
64239-404-10	2020-01-31	9d75b9d0-8242-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Donepezil Hydrochloride Tablets safely and effectively. See full prescribing information for Donepezil Hydrochloride Tablets. DONEPEZIL Hydrochloride Tablets, for oral use Initial U.S. Approval: 1996
64239-404-50	2020-01-31	9d75b9d0-8242-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Donepezil Hydrochloride Tablets safely and effectively. See full prescribing information for Donepezil Hydrochloride Tablets. DONEPEZIL Hydrochloride Tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64239-404-03	Donepezil Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	6
64239-404-10	Donepezil Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	6
64239-404-50	Donepezil Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64239-404	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DEXCEL PHARMA TECHNOLOGIES LTD.]	6	Legacy NDC, 3 package rows	20170214_04498589-1cbb-4008-80ce-f9f1ac57eb86.zip

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
Donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Edenbridge Pharmaceuticals LLC.	11404dc3-1bde-4d4e-8386-006b67ee19dd	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203713 application number: ANDA203713

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3O2T2PJ89D	DONEPEZIL HYDROCHLORIDE	120011-70-3	DONEPEZIL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1100184	donepezil HCl 23 MG Oral Tablet	PSN	04498589-1cbb-4008-80ce-f9f1ac57eb86	6
1100184	donepezil hydrochloride 23 MG Oral Tablet	SCD	04498589-1cbb-4008-80ce-f9f1ac57eb86	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64239-404-03	64239040403	30 in 1 BOTTLE, PLASTIC	Historical
64239-404-10	64239040410	100 in 1 BOTTLE, PLASTIC	Historical
64239-404-50	64239040450	500 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donepezil Hydrochloride	Dexcel Pharma Technologies Ltd. \| Institute for Food Microbiology and Consumer Goods Ltd. \| Dexcel Ltd. \| Neuland Laboratories Limited	2017-02-14	HUMAN PRESCRIPTION DRUG LABEL	6