Donepezil hydrochloride

Product NDC: 31722-139
11-digit product format: 317220139
Labeler code: 31722
Product ID: 31722-139_9d688237-1727-46ca-ba3c-efd830b12421
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA203907
Marketing category: ANDA
Marketing start: 2016-10-07
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	31722-139		I	Inactivated by FDA		2026-08-03
excluded package	package	31722-139	31722-139-10	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 · 42 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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`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	31722-139-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	31722-139-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	31722-139-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	31722-139-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	31722-139-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	31722-139-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	31722-139-10	`9bebd1f3094a…`	`5416666fcb17…`

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
A203907-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-10-29
A203907-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203907-001	AB
A203907-002	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	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`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	A203907-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203907-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203907-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203907-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203907-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203907-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203907-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203907-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203907-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203907-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203907-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203907-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203907-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203907-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203907-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203907-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203907-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203907-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203907-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203907-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203907-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203907-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203907-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203907-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203907-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203907-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203907-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203907-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203907-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203907-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203907-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203907-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203907-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203907-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203907-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203907-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203907-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203907-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203907-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203907-002	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
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
31722-139-10	2020-01-31	C162847	48780-1	9d75b9d0-313c-f424-e053-dadaa90a57ce	HIGHLIGHTS OF PRESCRIBING INFORMATION 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 These highlights do not include all the information neededto use DONEPEZIL HYDROCHLORIDE tablets safely and effectively. See fullprescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZILHYDROCHLO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
31722-139-10	Donepezil hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-139-10	EA - Each	31722-139	6293494a-d73b-4c84-aa57-b51f0d6b9a93	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-139	DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	1	Legacy NDC, 1 package rows	20161011_9d688237-1727-46ca-ba3c-efd830b12421.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	56abe961-ec94-4a77-b548-426f6255539e	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203907 application number: ANDA203907
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	6e9aacf9-abb6-4dec-9a8d-4eabf934d512	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203907 application number: ANDA203907

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3O2T2PJ89D	DONEPEZIL HYDROCHLORIDE	120011-70-3	DONEPEZIL HYDROCHLORIDE
8SSC91326P	DONEPEZIL	120014-06-4	Donepezil

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
997223	donepezil HCl 10 MG Oral Tablet	PSN	9d688237-1727-46ca-ba3c-efd830b12421	1
997229	donepezil HCl 5 MG Oral Tablet	PSN	9d688237-1727-46ca-ba3c-efd830b12421	1
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	9d688237-1727-46ca-ba3c-efd830b12421	1
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	9d688237-1727-46ca-ba3c-efd830b12421	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
31722-139-10	31722013910	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donepezil hydrochloride	Camber Pharmaceuticals, Inc. \| ScieGen Pharmaceuticals, Inc.	2016-10-07	Human Prescription Drug Label	1