Donepezil Hydrochloride

Product NDC: 71335-2022
11-digit product format: 713352022
Labeler code: 71335
Product ID: 71335-2022_c311f933-2648-4bf4-9328-a8c99ee8e9d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA201146
Marketing category: ANDA
Marketing start: 2012-08-17
Substance: DONEPEZIL HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A201146-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-08-17
A201146-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201146-001	AB
A201146-002	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	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`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	A201146-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201146-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201146-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201146-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201146-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201146-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201146-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201146-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201146-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201146-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201146-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201146-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201146-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201146-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201146-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201146-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201146-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201146-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Donepezil Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DONEPEZIL HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3O2T2PJ89D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997229	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
aa2c22b8-2dd4-4916-bc4f-9995eab74a6e	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2022-1	Donepezil Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	102
71335-2022-2	Donepezil Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	102
71335-2022-3	Donepezil Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2022	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 3 package rows	20240423_aa2c22b8-2dd4-4916-bc4f-9995eab74a6e.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	7620f41a-3eef-453b-a564-ea3c85374de2	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	ac857917-74db-4591-be9f-d1c822c68c81	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	4747633b-ac32-455e-8d50-ce9c481480c0	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	aa2c22b8-2dd4-4916-bc4f-9995eab74a6e	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146 ndc (product): 71335-2022
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	06dd25a5-1bf2-446d-ad75-ff9d55117660	2023-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	0c6b12e8-1933-40d8-bf43-97339b2b54fb	2023-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146

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	aa2c22b8-2dd4-4916-bc4f-9995eab74a6e	102
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	aa2c22b8-2dd4-4916-bc4f-9995eab74a6e	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-2022-1	71335202201	90 TABLET, FILM COATED in 1 BOTTLE (71335-2022-1)	2024-04-03	0000-00-00	No	No	Current
71335-2022-2	71335202202	30 TABLET, FILM COATED in 1 BOTTLE (71335-2022-2)	2021-12-22	0000-00-00	No	No	Current
71335-2022-3	71335202203	60 TABLET, FILM COATED in 1 BOTTLE (71335-2022-3)	2024-04-03	0000-00-00	No	No	Current