Application 090686

Type: ANDA
Sponsor: TORRENT PHARMS

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
A090686-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-05-31
A090686-002	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
A090686-001	AB
A090686-002	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	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090686-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090686-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090686-002	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	A090686-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090686-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090686-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090686-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090686-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090686-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090686-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090686-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090686-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090686-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090686-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090686-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090686-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090686-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090686-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090686-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090686-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090686-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090686-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090686-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090686-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090686-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090686-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090686-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090686-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090686-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090686-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090686-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090686-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090686-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090686-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090686-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090686-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090686-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090686-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090686-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090686-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090686-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090686-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090686-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Cardinal Health 107, LLC	c942a4c9-dbe5-4131-bb6c-aa2d31b387e7	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090686 application number: ANDA090686 ndc (product): 55154-7882 ndc (product): 55154-7883
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Major Pharmaceuticals	c777ddc9-0b61-4d6f-95d6-818ba1861d62	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090686 application number: ANDA090686 ndc (product): 0904-6478 ndc (product): 0904-6477
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Torrent Pharmaceuticals Limited	76bf638e-dbde-418e-8977-1caf009990bc	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090686 application number: ANDA090686 ndc (product): 13668-102 ndc (product): 13668-103

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7842	Donepezil Hydrochloride	Donepezil Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7843	Donepezil Hydrochloride	Donepezil Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6477	Donepezil Hydrochloride	Donepezil Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6477	Donepezil Hydrochloride	Donepezil Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6478	Donepezil Hydrochloride	Donepezil Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6478	Donepezil Hydrochloride	Donepezil Hydrochloride	Major Pharmaceuticals	ANDA	Current
13668-102	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-102	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-102	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-102	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-102	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-102	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-103	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-103	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-103	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-103	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-103	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-103	Donepezil Hydrochloride	Donepezil Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
50090-1285	Donepezil Hydrochloride	Donepezil Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1286	Donepezil Hydrochloride	Donepezil Hydrochloride	A-S Medication Solutions	ANDA	Current
55154-7882	Donepezil Hydrochloride	Donepezil Hydrochloride	Cardinal Health	ANDA	Current
55154-7882	Donepezil Hydrochloride	Donepezil Hydrochloride	Cardinal Health	ANDA	Current
55154-7882	Donepezil Hydrochloride	Donepezil Hydrochloride	Cardinal Health	ANDA	Current
55154-7883	Donepezil Hydrochloride	Donepezil Hydrochloride	Cardinal Health	ANDA	Current
55154-7883	Donepezil Hydrochloride	Donepezil Hydrochloride	Cardinal Health	ANDA	Current
55154-7883	Donepezil Hydrochloride	Donepezil Hydrochloride	Cardinal Health	ANDA	Current
67046-134	Donepezil Hydrochloride	Donepezil Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
67046-136	Donepezil Hydrochloride	Donepezil Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
68071-4008	Donepezil Hydrochloride	Donepezil Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68151-3114	Donepezil Hydrochloride	Donepezil Hydrochloride	Carilion Materials Management	ANDA	Current
70518-0802	Donepezil Hydrochloride	Donepezil Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0802	Donepezil Hydrochloride	Donepezil Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0582	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0582	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0582	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0582	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current