Donepezil Hyrochloride

Product NDC: 42582-311
11-digit product format: 425820311
Labeler code: 42582
Product ID: 42582-311_dc6e4127-412d-40b6-b313-46d489e7e181
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bi-Coastal Pharma International LLC
Application: ANDA090551
Marketing category: ANDA
Marketing start: 2015-07-01
Marketing end: 0000-00-00
Substance: DONEPEZIL HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	42582-311		I	Inactivated by FDA	2026-08-03
excluded package	package	42582-311	42582-311-09	I	Inactivated by FDA	2026-08-03
excluded package	package	42582-311	42582-311-18	I	Inactivated by FDA	2026-08-03
excluded package	package	42582-311	42582-311-30	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 1 · 60 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	42582-311-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42582-311-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42582-311-18	`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	42582-311-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42582-311-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42582-311-18	`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	42582-311-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42582-311-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42582-311-18	`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	42582-311-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42582-311-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42582-311-18	`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	42582-311-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42582-311-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42582-311-18	`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	42582-311-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42582-311-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42582-311-18	`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	42582-311-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42582-311-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42582-311-18	`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	42582-311-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42582-311-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42582-311-18	`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	42582-311-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42582-311-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42582-311-18	`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	42582-311-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42582-311-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42582-311-18	`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	42582-311-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42582-311-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42582-311-18	`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	42582-311-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42582-311-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42582-311-18	`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	42582-311-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42582-311-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42582-311-18	`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	42582-311-09	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42582-311-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42582-311-18	`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	42582-311-09	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42582-311-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42582-311-18	`1332a3947898…`	`d4bfe170f9cd…`

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
A090551-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-05-31
A090551-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2011-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090551-001	AB
A090551-002	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 3 · 82 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	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090551-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090551-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090551-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090551-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090551-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090551-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090551-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090551-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090551-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090551-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090551-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090551-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090551-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090551-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090551-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090551-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090551-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090551-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090551-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090551-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090551-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090551-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090551-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090551-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090551-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090551-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090551-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090551-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090551-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090551-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090551-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090551-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090551-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090551-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090551-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090551-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090551-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090551-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090551-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090551-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
94db636e-a074-45fd-8e8d-331920a99436	Product name	4	20250103
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7	Product name	1	20221214
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d7e50b51-94ef-29ef-8273-837d555048c1	Product name	9	20160811
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42582-311-09	2023-01-30	C162847	48780-1	f386c649-aa90-0266-e053-dadaa90a7c1a	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
42582-311-18	2023-01-30	C162847	48780-1	f386c649-aa90-0266-e053-dadaa90a7c1a	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
42582-311-30	2023-01-30	C162847	48780-1	f386c649-aa90-0266-e053-dadaa90a7c1a	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
42582-311-09	Donepezil Hyrochloride5mg	90 in 1 BOTTLE	TABLET, FILM COATED	90	3
42582-311-18	Donepezil Hyrochloride5mg	500 in 1 BOTTLE	TABLET, FILM COATED	500	3
42582-311-30	Donepezil Hyrochloride5mg	30 in 1 BOTTLE	TABLET, FILM COATED	30	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42582-311-09	EA - Each	42582-311	b847b610-c5ab-4485-92ff-4b0f50f2df31	1	2018-03-08
42582-311-30	EA - Each	42582-311	d45f168f-4625-4869-8a69-0160e0976616	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42582-311	DONEPEZIL HYROCHLORIDE 5MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE 10MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [BI‐COASTAL PHARMA INTERNATIONAL LLC]	3	Legacy NDC, 3 package rows	20190109_6ba90d01-3a96-4780-99df-2b4af8c3ea38.zip

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
997223	donepezil HCl 10 MG Oral Tablet	PSN	6ba90d01-3a96-4780-99df-2b4af8c3ea38	3
997229	donepezil HCl 5 MG Oral Tablet	PSN	6ba90d01-3a96-4780-99df-2b4af8c3ea38	3
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	6ba90d01-3a96-4780-99df-2b4af8c3ea38	3
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	6ba90d01-3a96-4780-99df-2b4af8c3ea38	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42582-311-09	42582031109	90 TABLET, FILM COATED in 1 BOTTLE (42582-311-09)	2016-10-05	0000-00-00	No	No	Current
42582-311-18	42582031118	500 TABLET, FILM COATED in 1 BOTTLE (42582-311-18)	2016-10-05	0000-00-00	No	No	Current
42582-311-30	42582031130	30 TABLET, FILM COATED in 1 BOTTLE (42582-311-30)	2016-10-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donepezil Hyrochloride 5mg	Bi‐Coastal Pharma International LLC \| Strides Vivimed Pte. Ltd. \| Vivimed Life Sciences Private Limited	2019-01-09	HUMAN PRESCRIPTION DRUG LABEL	3