Donepezil Hydrochloride

Product NDC: 64679-311
11-digit product format: 646790311
Labeler code: 64679
Product ID: 64679-311_95138de5-e19d-4bff-98eb-e205d8f2b044
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Wockhardt USA LLC.
Application: ANDA091267
Marketing category: ANDA
Marketing start: 2011-05-28
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: 2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64679-311		D	Discontinued by firm	2026-08-03
excluded package	package	64679-311	64679-311-01	D	Discontinued by firm	2026-08-03
excluded package	package	64679-311	64679-311-02	D	Discontinued by firm	2026-08-03
excluded package	package	64679-311	64679-311-03	D	Discontinued by firm	2026-08-03
excluded package	package	64679-311	64679-311-04	D	Discontinued by firm	2026-08-03
excluded package	package	64679-311	64679-311-05	D	Discontinued by firm	2026-08-03
excluded package	package	64679-311	64679-311-06	D	Discontinued by firm	2026-08-03
excluded package	package	64679-311	64679-311-07	D	Discontinued by firm	2026-08-03
excluded package	package	64679-311	64679-311-08	D	Discontinued by firm	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 4 · 189 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	64679-311-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-311-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-311-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-311-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-311-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-311-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-311-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-311-02	`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	64679-311-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-311-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-311-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-311-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-311-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-311-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-311-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-311-02	`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	64679-311-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-311-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-311-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-311-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-311-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-311-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-311-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-311-02	`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	64679-311-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-311-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-311-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-311-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-311-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-311-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-311-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-311-02	`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	64679-311-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-311-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-311-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-311-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-311-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-311-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-311-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-311-02	`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	64679-311-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-311-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-311-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-311-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-311-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-311-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-311-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-311-02	`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	64679-311-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-311-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-311-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-311-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-311-08	`302b2466d912…`	`e7b80fea0513…`

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
A091267-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL			2011-05-31
A091267-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL			2011-05-31

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091267-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2011-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091267-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2011-05-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A091267-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091267-002	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-311-01	2024-10-29	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 Initial U.S. Approval: 1996
64679-311-02	2024-10-29	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 Initial U.S. Approval: 1996
64679-311-03	2024-10-29	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 Initial U.S. Approval: 1996
64679-311-04	2024-10-29	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 Initial U.S. Approval: 1996
64679-311-05	2024-10-29	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 Initial U.S. Approval: 1996
64679-311-06	2024-10-29	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 Initial U.S. Approval: 1996
64679-311-07	2024-10-29	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 Initial U.S. Approval: 1996
64679-311-08	2024-10-29	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 Initial U.S. Approval: 1996
64679-311-01	2020-01-31	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 Initial U.S. Approval: 1996
64679-311-02	2020-01-31	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 Initial U.S. Approval: 1996
64679-311-03	2020-01-31	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 Initial U.S. Approval: 1996
64679-311-04	2020-01-31	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 Initial U.S. Approval: 1996
64679-311-05	2020-01-31	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 Initial U.S. Approval: 1996
64679-311-06	2020-01-31	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 Initial U.S. Approval: 1996
64679-311-07	2020-01-31	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 Initial U.S. Approval: 1996
64679-311-08	2020-01-31	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 Initial U.S. Approval: 1996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-311-01	EA - Each	64679-311	0561b9c0-0882-4be8-9394-369e1e3733a5	1	2012-07-24
64679-311-03	EA - Each	64679-311	317926c1-9c3c-4cc9-8e1f-7e9cd4198548	1	2012-07-24
64679-311-05	EA - Each	64679-311	cfb01ba5-8ee3-4be2-8552-68297e1939b0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DONEPEZIL HYDROCHLORIDE	ACTIVE INGREDIENT	3O2T2PJ89D	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
DONEPEZIL	ACTIVE MOIETY	8SSC91326P	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donepezil Hydrochloride	Wockhardt USA LLC. \| Wockhardt Limited	2018-12-07	HUMAN PRESCRIPTION DRUG LABEL	3