Donepezil Hydrochloride

Product NDC: 71335-0876
Requested package NDC: 71335-0876-2
11-digit product format: 713350876
Labeler code: 71335
Product ID: 71335-0876_3ac29f6f-0993-416f-8352-e6c0a5ef3e55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA201724
Marketing category: ANDA
Marketing start: 2016-01-29
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0876	71335-0876-2	I	Inactivated by FDA		2026-08-10

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A201724-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-02-25
A201724-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2013-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201724-001	AB
A201724-002	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	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201724-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-02-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201724-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2013-02-25	`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	A201724-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201724-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201724-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201724-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201724-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201724-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201724-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201724-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201724-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201724-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201724-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201724-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201724-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201724-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201724-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201724-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201724-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201724-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201724-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201724-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201724-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201724-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201724-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201724-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201724-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201724-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201724-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201724-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201724-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201724-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201724-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201724-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201724-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201724-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201724-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201724-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201724-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201724-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201724-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201724-002	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
71335-0876-1	2024-01-30	C162847	48780-1	1030e365-1747-111a-e063-dadaa90a10e2	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
71335-0876-2	2024-01-30	C162847	48780-1	1030e365-1747-111a-e063-dadaa90a10e2	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
71335-0876-3	2024-01-30	C162847	48780-1	1030e365-1747-111a-e063-dadaa90a10e2	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
71335-0876-1	Donepezil Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	4
71335-0876-2	Donepezil Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
71335-0876-3	Donepezil Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0876	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	4	Legacy NDC, 3 package rows	20220202_3ac29f6f-0993-416f-8352-e6c0a5ef3e55.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	Alembic Pharmaceuticals Limited	bc570682-413b-46fb-a069-c2986884bfce	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201724 application number: ANDA201724
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	9407258b-60ed-4884-a903-885aeedaddf8	2021-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201724 application number: ANDA201724

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
997229	donepezil HCl 5 MG Oral Tablet	PSN	3ac29f6f-0993-416f-8352-e6c0a5ef3e55	4
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	3ac29f6f-0993-416f-8352-e6c0a5ef3e55	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0876-2	71335087602	30 TABLET, FILM COATED in 1 BOTTLE (71335-0876-2)	2018-10-23	0000-00-00	No	No	Current