Application 203034

Type: ANDA
Sponsor: HETERO LABS LTD V

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
A203034-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2015-01-30
A203034-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2015-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203034-001	AB
A203034-002	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	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`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	A203034-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203034-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203034-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203034-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203034-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203034-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203034-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203034-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203034-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203034-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203034-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203034-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203034-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203034-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203034-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203034-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203034-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203034-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203034-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203034-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203034-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203034-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203034-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203034-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203034-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203034-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203034-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203034-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203034-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203034-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203034-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203034-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203034-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203034-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203034-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203034-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203034-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203034-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203034-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203034-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	84d8ca68-26f3-4dd5-9dd4-6a7525a30db1	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203034 application number: ANDA203034 ndc (product): 50090-2910 ndc (product): 50090-2627
Donepezil	DONEPEZIL HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	c7e1f642-1bdc-4ed6-9b9e-c1af40b926cd	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203034 application number: ANDA203034
Donepezil	DONEPEZIL HYDROCHLORIDE	American Health Packaging	12ae85f0-023c-49ca-8c4a-0a6a7585290e	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203034 application number: ANDA203034 ndc (product): 60687-303 ndc (product): 60687-292
Donepezil	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	37fc6638-4a63-4582-a64c-3525f8ed7ef2	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203034 application number: ANDA203034
Donepezil	DONEPEZIL HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	11ac01f4-d26e-47b2-9660-d514ab097fdb	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203034 application number: ANDA203034 ndc (product): 31722-738 ndc (product): 31722-737

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-737	Donepezil	Donepezil hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-737	Donepezil	Donepezil hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-738	Donepezil	Donepezil hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-738	Donepezil	Donepezil hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-2627	Donepezil	Donepezil hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2627	Donepezil	Donepezil hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2627	Donepezil	Donepezil hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2627	Donepezil	Donepezil hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2627	Donepezil	Donepezil hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2627	Donepezil	Donepezil hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2910	Donepezil hydrochloride	Donepezil hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2910	Donepezil	Donepezil hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2910	Donepezil hydrochloride	Donepezil hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2910	Donepezil hydrochloride	Donepezil hydrochloride	A-S Medication Solutions	ANDA	Current
60687-292	Donepezil	Donepezil hydrochloride	American Health Packaging	ANDA	Current
60687-292	Donepezil	Donepezil hydrochloride	American Health Packaging	ANDA	Current
60687-292	Donepezil	Donepezil hydrochloride	American Health Packaging	ANDA	Current
60687-303	Donepezil	Donepezil hydrochloride	American Health Packaging	ANDA	Current
60687-303	Donepezil	Donepezil hydrochloride	American Health Packaging	ANDA	Current
60687-303	Donepezil	Donepezil hydrochloride	American Health Packaging	ANDA	Current
68071-3183	Donepezil	Donepezil hydrochloride	NuCarePharmaceuticals, Inc.	ANDA	Current
68071-3192	Donepezil	Donepezil hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3198	Donepezil	Donepezil hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3198	Donepezil	Donepezil hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3198	Donepezil	Donepezil hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4613	Donepezil	Donepezil hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4613	Donepezil	Donepezil hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4615	Donepezil	Donepezil hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4615	Donepezil	Donepezil hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68554-5037	Donepezil Hydrochloride	Donepezil Hydrochloride	Hetero Labs Limited	ANDA	Current
68554-5038	Donepezil Hydrochloride	Donepezil Hydrochloride	Hetero Labs Limited	ANDA	Current
68788-7632	Donepezil	Donepezil hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0792	Donepezil	Donepezil hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0792	Donepezil	Donepezil hydrochloride	Bryant Ranch Prepack	ANDA	Current