Donepezil Hydrochloride

Product NDC: 43063-659
11-digit product format: 430630659
Labeler code: 43063
Product ID: 43063-659_efe3f984-3fc7-0bfe-e053-2995a90a98aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA201146
Marketing category: ANDA
Marketing start: 2012-08-17
Marketing end: 0000-00-00
Substance: DONEPEZIL HYDROCHLORIDE
Active strength: 10 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	43063-659		D	Discontinued by firm		2026-10-15
excluded package	package	43063-659	43063-659-30	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A201146-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-08-17
A201146-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201146-001	AB
A201146-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201146-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201146-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201146-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201146-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201146-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201146-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201146-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201146-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201146-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201146-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201146-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201146-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201146-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201146-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201146-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201146-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201146-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201146-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201146-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201146-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201146-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201146-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201146-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201146-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201146-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201146-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201146-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201146-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201146-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201146-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201146-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201146-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201146-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201146-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201146-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201146-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201146-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201146-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201146-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201146-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-659-90	EA - Each	43063-659	35cad6ca-4a2b-46dc-ac03-f03d2913c5f8	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-659	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	22	Legacy NDC	20241016_2be9f49d-e7db-4846-e054-00144ff8d46c.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	7620f41a-3eef-453b-a564-ea3c85374de2	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	ac857917-74db-4591-be9f-d1c822c68c81	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	4747633b-ac32-455e-8d50-ce9c481480c0	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	aa2c22b8-2dd4-4916-bc4f-9995eab74a6e	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	06dd25a5-1bf2-446d-ad75-ff9d55117660	2023-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	0c6b12e8-1933-40d8-bf43-97339b2b54fb	2023-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146

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
43063-659-90	43063065990	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-659-90)	2016-03-04	0000-00-00	No	No	Current