Application 078662

Type: ANDA
Sponsor: ACI HEALTHCARE LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

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…`

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 ndc (product): 71335-2065
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): 71093-127 ndc (product): 71093-128

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71093-127	Donepezil Hydrochloride	Donepezil Hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-127	Donepezil Hydrochloride	Donepezil Hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-127	Donepezil Hydrochloride	Donepezil Hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-127	Donepezil Hydrochloride	Donepezil Hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-127	Donepezil Hydrochloride	Donepezil Hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-128	Donepezil Hydrochloride	Donepezil Hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-128	Donepezil Hydrochloride	Donepezil Hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-128	Donepezil Hydrochloride	Donepezil Hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-128	Donepezil Hydrochloride	Donepezil Hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-128	Donepezil Hydrochloride	Donepezil Hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71335-2065	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-2065	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current