Application 090056

Type: ANDA
Sponsor: AUROBINDO

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
A090056-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-05-31
A090056-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2011-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090056-001	AB
A090056-002	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	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`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	A090056-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090056-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090056-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090056-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090056-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090056-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090056-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090056-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090056-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090056-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090056-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090056-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090056-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090056-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090056-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090056-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090056-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090056-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090056-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090056-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090056-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090056-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090056-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090056-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090056-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090056-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090056-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090056-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090056-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090056-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090056-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090056-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090056-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090056-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090056-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090056-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090056-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090056-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090056-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090056-002	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 · 9 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.	8138f616-83f3-4c47-84ef-1bce2db339f7	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056 ndc (product): 68788-8208
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	de96349a-5fee-4de9-921c-e453d44b3203	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	e2ab403a-ec2d-44e7-9da1-66d0a7443f1d	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Coupler LLC	2d01fb96-c825-fad5-e063-6394a90ac6cc	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	0516d548-db9b-410a-aec9-79aedbc3f6e9	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	c030fd7c-da5c-457a-a825-1767bd87d04d	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056 ndc (product): 71335-2093
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Aurobindo Pharma Limited	3257494f-8f44-4978-b92d-bde87b2444b6	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056 ndc (product): 65862-325 ndc (product): 65862-326
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Rising Pharma Holdings, Inc.	86b0c5a0-ff3c-4840-a4ac-82af922d58bf	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056 ndc (product): 16571-779 ndc (product): 16571-778

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-778	Donepezil Hydrochloride	Donepezil Hydrochloride	Rising Pharma Holdings, Inc.	ANDA	Current
16571-779	Donepezil Hydrochloride	Donepezil Hydrochloride	Rising Pharma Holdings, Inc.	ANDA	Current
52343-089	Donepezil Hydrochloride	Donepezil Hydrochloride	LUCID PHARMA LLC	ANDA	Current
52343-089	Donepezil Hydrochloride	Donepezil Hydrochloride	ACETRIS HEALTH, LLC	ANDA	Current
52343-090	Donepezil Hydrochloride	Donepezil Hydrochloride	LUCID PHARMA LLC	ANDA	Current
52343-090	Donepezil Hydrochloride	Donepezil Hydrochloride	ACETRIS HEALTH, LLC	ANDA	Current
57237-192	Donepezil Hydrochloride	Donepezil Hydrochloride	Citron Pharma LLC	ANDA	Current
57237-193	Donepezil Hydrochloride	Donepezil Hydrochloride	Citron Pharma LLC	ANDA	Current
65862-325	Donepezil Hydrochloride	Donepezil Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-325	Donepezil Hydrochloride	Donepezil Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-325	Donepezil Hydrochloride	Donepezil Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-326	Donepezil Hydrochloride	Donepezil Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-326	Donepezil Hydrochloride	Donepezil Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-326	Donepezil Hydrochloride	Donepezil Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
68788-8208	Donepezil Hydrochloride	Donepezil Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-2093	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current