Application 090551

Type: ANDA
Sponsor: STRIDES PHARMA

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
A090551-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-05-31
A090551-002	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
A090551-001	AB
A090551-002	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	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090551-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090551-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090551-002	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	A090551-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090551-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090551-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090551-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090551-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090551-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090551-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090551-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090551-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090551-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090551-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090551-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090551-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090551-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090551-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090551-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090551-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090551-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090551-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090551-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090551-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090551-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090551-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090551-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090551-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090551-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090551-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090551-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090551-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090551-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090551-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090551-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090551-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090551-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090551-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090551-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090551-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090551-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090551-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090551-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	a085ed33-c262-44ab-e053-2a95a90a5557	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	12a755c5-1ad9-43d1-832a-eb2ff17bd693	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Cardinal Health 107, LLC	c942a4c9-dbe5-4131-bb6c-aa2d31b387e7	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ee54a472-6783-41df-b8bb-9c3e4c996907	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8138f616-83f3-4c47-84ef-1bce2db339f7	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	41c095b6-acd9-4627-a813-bbca7ecafee5	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	56abe961-ec94-4a77-b548-426f6255539e	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Major Pharmaceuticals	c777ddc9-0b61-4d6f-95d6-818ba1861d62	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Torrent Pharmaceuticals Limited	76bf638e-dbde-418e-8977-1caf009990bc	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	6e9aacf9-abb6-4dec-9a8d-4eabf934d512	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	84d8ca68-26f3-4dd5-9dd4-6a7525a30db1	2026-01-20	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	1a8906ce-96dc-4bc8-81c1-5db67a187aac	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	c7e1f642-1bdc-4ed6-9b9e-c1af40b926cd	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	American Health Packaging	12ae85f0-023c-49ca-8c4a-0a6a7585290e	2025-09-24	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Edenbridge Pharmaceuticals LLC.	11404dc3-1bde-4d4e-8386-006b67ee19dd	2025-08-01	Warnings, Adverse reactions	Name fallback brand name: Donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	de96349a-5fee-4de9-921c-e453d44b3203	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	37fc6638-4a63-4582-a64c-3525f8ed7ef2	2025-07-02	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Solco Healthcare US, LLC	48178cb4-4fee-47c0-88e9-a4f017f1f448	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Solco Healthcare US, LLC	042a59ea-131a-4806-b0f4-2f791d4414e2	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
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

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
42582-311	Donepezil Hyrochloride	Donepezil Hydrochloride	Bi-Coastal Pharma International LLC	ANDA	Current
42582-312	Donepezil Hydrochloride	Donepezil Hydrochloride	Bi-Coastal Pharma International LLC	ANDA	Current
62980-504	Donepezil Hyrochloride	Donepezil Hydrochloride	Vivimed Labs Limited	ANDA	Current
62980-505	Donepezil Hydrochloride	Donepezil Hydrochloride	Vivimed Labs Limited	ANDA	Current
62980-907	Donepezil Hyrochloride	Donepezil Hydrochloride	Vivimed Labs Limited	ANDA	Current
62980-908	Donepezil Hyrochloride	Donepezil Hydrochloride	Vivimed Labs Limited	ANDA	Current
64380-907	Donepezil Hyrochloride	Donepezil Hydrochloride	Strides Pharma Inc.	ANDA	Current
64380-907	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current
64380-908	Donepezil Hydrochloride	Donepezil Hydrochloride	Strides Pharma Inc.	ANDA	Current
64380-908	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current
69150-415	Donepezil Hydrochloride	donepezil hydrochloride	BIOMES PHARMACEUTICALS LLC	ANDA	Current
69150-416	Donepezil Hydrochloride	donepezil hydrochloride	BIOMES PHARMACEUTICALS LLC	ANDA	Current