Application 090100

Type: ANDA
Sponsor: CADILA

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 43.

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
A090100-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-10-24
A090100-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090100-001	AB
A090100-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090100-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090100-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090100-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090100-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090100-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090100-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090100-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090100-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090100-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090100-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090100-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090100-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090100-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090100-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090100-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090100-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090100-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090100-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090100-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090100-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090100-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090100-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090100-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090100-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090100-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090100-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090100-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090100-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090100-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090100-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090100-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090100-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090100-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090100-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090100-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090100-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090100-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090100-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090100-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090100-002	AB	1	`74a2ff9319b5…`

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 2 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	e2ab403a-ec2d-44e7-9da1-66d0a7443f1d	2025-06-05	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Dr. Reddys Laboratories Limited	7c0d3bcb-157d-0414-64ee-055bc614d190	2025-04-11	Warnings, Adverse reactions	Name fallback brand name: Donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Coupler LLC	2d01fb96-c825-fad5-e063-6394a90ac6cc	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	Direct_Rx	93dddf28-094b-dd8c-e053-2995a90a63e9	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: DONEPEZIL HYDROCHLORIDE generic name: DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	DirectRx	cb1b3ed1-6e68-08e2-e053-2995a90a68c4	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: DONEPEZIL HYDROCHLORIDE generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	7620f41a-3eef-453b-a564-ea3c85374de2	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	11ac01f4-d26e-47b2-9660-d514ab097fdb	2025-01-07	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	03e26183-3e07-45e8-a414-a8bad32483e2	2024-11-29	Warnings, Adverse reactions	Name fallback brand name: DONEPEZIL HYDROCHLORIDE generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	ac857917-74db-4591-be9f-d1c822c68c81	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	c030fd7c-da5c-457a-a825-1767bd87d04d	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	4747633b-ac32-455e-8d50-ce9c481480c0	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	aa2c22b8-2dd4-4916-bc4f-9995eab74a6e	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	8090bff0-e0f0-4846-a2ab-cb28a0a2648d	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	caebc31c-5a35-4434-b7e2-80f6405383ca	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Aurobindo Pharma Limited	3257494f-8f44-4978-b92d-bde87b2444b6	2024-01-08	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Rising Pharma Holdings, Inc.	86b0c5a0-ff3c-4840-a4ac-82af922d58bf	2024-01-08	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	c26d9bf3-e148-48bb-8f4f-e8c73804b311	2023-11-17	Warnings, Adverse reactions	Name fallback brand name: donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	06dd25a5-1bf2-446d-ad75-ff9d55117660	2023-08-11	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	5d46ef3c-0dee-4389-a2d5-997ea8342817	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
65841-749	donepezil hydrochloride	donepezil hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-749	donepezil hydrochloride	donepezil hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-749	donepezil hydrochloride	donepezil hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-749	donepezil hydrochloride	donepezil hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-750	donepezil hydrochloride	donepezil hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-750	donepezil hydrochloride	donepezil hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-750	donepezil hydrochloride	donepezil hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-750	donepezil hydrochloride	donepezil hydrochloride	Cadila Healthcare Limited	ANDA	Current
68382-302	donepezil hydrochloride	donepezil hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-302	donepezil hydrochloride	donepezil hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-303	donepezil hydrochloride	donepezil hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-303	donepezil hydrochloride	donepezil hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current