Donepezil Hydrochloride

Product NDC: 51407-320
Requested package NDC: 51407-320-30
11-digit product format: 514070320
Labeler code: 51407
Product ID: 51407-320_2eeb3c61-4ceb-d8ed-e063-6294a90a00d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA203104
Marketing category: ANDA
Marketing start: 2014-10-29
Marketing end: 2027-01-31
Substance: DONEPEZIL HYDROCHLORIDE
Active strength: 23 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203104-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB		2014-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203104-001	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 2 · 41 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	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A203104-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203104-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203104-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203104-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203104-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203104-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203104-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203104-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203104-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203104-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203104-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203104-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203104-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203104-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203104-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203104-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203104-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203104-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203104-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203104-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203104-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203104-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203104-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203104-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203104-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203104-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203104-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203104-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203104-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203104-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203104-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203104-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203104-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203104-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203104-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203104-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203104-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203104-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203104-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203104-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Donepezil Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DONEPEZIL HYDROCHLORIDE	23 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3O2T2PJ89D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1100184	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a085ed33-c262-44ab-e053-2a95a90a5557	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
94db636e-a074-45fd-8e8d-331920a99436	Product name	4	20250103
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7	Product name	1	20221214
d7e50b51-94ef-29ef-8273-837d555048c1	Product name	9	20160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51407-320-30	Donepezil Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-320-30	EA - Each	51407-320	759ece1c-fd36-47d3-91fb-f8703023eeb1	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-320	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20250411_a085ed33-c262-44ab-e053-2a95a90a5557.zip

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 Hydrochloride	DONEPEZIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	a085ed33-c262-44ab-e053-2a95a90a5557	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203104 application number: ANDA203104 ndc (package): 51407-320-30 ndc (product): 51407-320 ndc11 (package): 51407032030
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	12a755c5-1ad9-43d1-832a-eb2ff17bd693	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203104 application number: ANDA203104
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	8090bff0-e0f0-4846-a2ab-cb28a0a2648d	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203104 application number: ANDA203104
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	caebc31c-5a35-4434-b7e2-80f6405383ca	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203104 application number: ANDA203104
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Proficient Rx LP	32709bda-53d0-4d57-9f0b-3e1f28e39f25	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203104 application number: ANDA203104

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3O2T2PJ89D	DONEPEZIL HYDROCHLORIDE	120011-70-3	DONEPEZIL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1100184	donepezil HCl 23 MG Oral Tablet	PSN	a085ed33-c262-44ab-e053-2a95a90a5557	7
1100184	donepezil hydrochloride 23 MG Oral Tablet	SCD	a085ed33-c262-44ab-e053-2a95a90a5557	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-320-30	51407032030	30 TABLET, FILM COATED in 1 BOTTLE (51407-320-30)	2020-01-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donepezil Hydrochloride	Golden State Medical Supply, Inc.	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	7