Donepezil Hydrochloride

Product NDC: 71093-128
11-digit product format: 710930128
Labeler code: 71093
Product ID: 71093-128_a4736add-da84-411f-8e6f-9de67bf467f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: ACI Healthcare USA, Inc.
Application: ANDA078662
Marketing category: ANDA
Marketing start: 2021-06-29
Substance: DONEPEZIL HYDROCHLORIDE
Active strength: 10 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
A078662-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL			2011-05-31
A078662-002	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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078662-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078662-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A078662-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078662-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078662-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078662-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078662-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078662-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078662-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078662-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078662-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078662-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078662-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078662-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078662-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078662-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078662-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078662-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078662-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078662-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078662-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078662-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078662-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078662-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078662-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078662-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078662-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078662-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078662-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078662-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078662-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078662-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078662-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078662-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078662-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078662-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078662-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078662-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078662-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078662-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078662-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078662-002	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	10 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997223	Internal RxNorm lookup
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
297e86e8-d248-4cc9-9d9c-2ef9efb4414d	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
71093-128-01	Donepezil Hydrochloride	30 in 1 BOTTLE	TABLET	30	10
71093-128-03	Donepezil Hydrochloride	90 in 1 BOTTLE	TABLET	90	10
71093-128-05	Donepezil Hydrochloride	500 in 1 BOTTLE	TABLET	500	10
71093-128-06	Donepezil Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71093-128-01	EA - Each	71093-128	cc87d038-c744-4378-82fa-f67e6557ca60	1	2021-09-07
71093-128-03	EA - Each	71093-128	c2d65cdb-d4e0-4cd3-8687-a87139fe1fc3	1	2021-09-07
71093-128-05	EA - Each	71093-128	17e54205-03d6-4159-8631-f261d9171718	1	2021-09-07
71093-128-06	EA - Each	71093-128	b05fcae7-9578-410c-8ba5-f0bf031db6b1	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71093-128	DONEPEZIL HYDROCHLORIDE TABLET [ACI HEALTHCARE USA, INC.]	10	Current NDC, Legacy NDC, 4 package rows	20231213_297e86e8-d248-4cc9-9d9c-2ef9efb4414d.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	Preferred Pharmaceuticals Inc.	ee54a472-6783-41df-b8bb-9c3e4c996907	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078662 application number: ANDA078662
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	385d2fb5-814c-44bd-ac7b-8857d18f144b	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078662 application number: ANDA078662
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	7ab9d0ef-e30c-46e9-9911-435a7b65c47b	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078662 application number: ANDA078662
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	7db089de-0344-4246-81b7-7c88a2a18402	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078662 application number: ANDA078662
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	ecf91436-9de1-44bb-8366-8551479c86a9	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078662 application number: ANDA078662
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	ACI Healthcare USA, Inc.	297e86e8-d248-4cc9-9d9c-2ef9efb4414d	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078662 application number: ANDA078662 ndc (product): 71093-128

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	7ab9d0ef-e30c-46e9-9911-435a7b65c47b	102
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	7ab9d0ef-e30c-46e9-9911-435a7b65c47b	102
997223	donepezil HCl 10 MG Oral Tablet	PSN	297e86e8-d248-4cc9-9d9c-2ef9efb4414d	10
997229	donepezil HCl 5 MG Oral Tablet	PSN	297e86e8-d248-4cc9-9d9c-2ef9efb4414d	10
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	297e86e8-d248-4cc9-9d9c-2ef9efb4414d	10
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	297e86e8-d248-4cc9-9d9c-2ef9efb4414d	10
997223	donepezil HCl 10 MG Oral Tablet	PSN	7db089de-0344-4246-81b7-7c88a2a18402	1
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	7db089de-0344-4246-81b7-7c88a2a18402	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71093-128-01	71093012801	30 TABLET in 1 BOTTLE (71093-128-01)	30 tablet	2021-06-29	0000-00-00	No	No	Current
71093-128-03	71093012803	90 TABLET in 1 BOTTLE (71093-128-03)	90 tablet	2021-06-29	0000-00-00	No	No	Current
71093-128-05	71093012805	500 TABLET in 1 BOTTLE (71093-128-05)	500 tablet	2021-06-29	0000-00-00	No	No	Current
71093-128-06	71093012806	1000 TABLET in 1 BOTTLE (71093-128-06)	1000 tablet	2021-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donepezil Hydrochloride	Bryant Ranch Prepack	2024-11-07	HUMAN PRESCRIPTION DRUG LABEL	102
Donepezil Hydrochloride	Bryant Ranch Prepack	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	1
Donepezil Hydrochloride	ACI Healthcare USA, Inc. \| ACI HealthCare Limited \| Elysium Pharmaceuticals Ltd \| InvaTech Pharma Solutions LLC	2023-12-11	Human Prescription Drug Label	10