donepezil hydrochloride

Product NDC: 63629-1118
11-digit product format: 636291118
Labeler code: 63629
Product ID: 63629-1118_b0d47ed5-1cc8-4bf0-80e9-75361afa9993
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: donepezil hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203713
Marketing category: ANDA
Marketing start: 2020-07-30
Marketing end: 0000-00-00
Substance: DONEPEZIL HYDROCHLORIDE
Active strength: 23 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-1118		D	Discontinued by firm		2026-08-03
excluded package	package	63629-1118	63629-1118-1	D	Discontinued by firm		2026-08-03

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
A203713-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB		2016-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203713-001	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	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203713-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2016-02-19	`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	A203713-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203713-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203713-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203713-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203713-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203713-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203713-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203713-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203713-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203713-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203713-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203713-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203713-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203713-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203713-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203713-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203713-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203713-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203713-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203713-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203713-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203713-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203713-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203713-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203713-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203713-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203713-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203713-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203713-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203713-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203713-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203713-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203713-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203713-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203713-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203713-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203713-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203713-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203713-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203713-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1118-1	EA - Each	63629-1118	1732f2b3-bba1-4e42-be4d-8f9931c2cbf4	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1118	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	3	Legacy NDC	20230223_045529cb-0a13-41fc-96db-f9e26b7db312.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Edenbridge Pharmaceuticals LLC.	11404dc3-1bde-4d4e-8386-006b67ee19dd	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203713 application number: ANDA203713

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1118-1	63629111801	90 TABLET, FILM COATED in 1 BOTTLE (63629-1118-1)	2020-07-30	0000-00-00	No	No	Current