donepezil hydrochloride

Product NDC: 67046-144
Requested package NDC: 67046-144-21
11-digit product format: 670460144
Labeler code: 67046
Product ID: 67046-144_7d660533-be78-7ee4-e053-2a91aa0a7baf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: donepezil hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA200292
Marketing category: ANDA
Marketing start: 2017-09-19
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67046-144	67046-144-21	I	Inactivated by FDA		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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200292-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-05-31
A200292-002	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
A200292-001	AB
A200292-002	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 2 · 60 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
2024-07-13 05:37 UTC	2024-07	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC	2024-07	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC	2024-07	A200292-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC	2024-07	A200292-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200292-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200292-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200292-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200292-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200292-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200292-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200292-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200292-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200292-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200292-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200292-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200292-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200292-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200292-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200292-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200292-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200292-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200292-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200292-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200292-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200292-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200292-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200292-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200292-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200292-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200292-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200292-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200292-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200292-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200292-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200292-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200292-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200292-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200292-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200292-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200292-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200292-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200292-002	AB	1	`a72a2bbeb626…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	41c095b6-acd9-4627-a813-bbca7ecafee5	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200292 application number: ANDA200292
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Solco Healthcare US, LLC	48178cb4-4fee-47c0-88e9-a4f017f1f448	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200292 application number: ANDA200292
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Solco Healthcare US, LLC	042a59ea-131a-4806-b0f4-2f791d4414e2	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200292 application number: ANDA200292
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	Direct_Rx	93dddf28-094b-dd8c-e053-2995a90a63e9	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200292 application number: ANDA200292
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	DirectRx	cb1b3ed1-6e68-08e2-e053-2995a90a68c4	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200292 application number: ANDA200292
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	c26d9bf3-e148-48bb-8f4f-e8c73804b311	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200292 application number: ANDA200292
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	5d46ef3c-0dee-4389-a2d5-997ea8342817	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200292 application number: ANDA200292

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67046-144-07	2022-01-28	C162847	48780-1	d6a99b39-3545-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use 144 Initial U.S. Approval: 1996
67046-144-14	2022-01-28	C162847	48780-1	d6a99b39-3545-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use 144 Initial U.S. Approval: 1996
67046-144-15	2022-01-28	C162847	48780-1	d6a99b39-3545-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use 144 Initial U.S. Approval: 1996
67046-144-21	2022-01-28	C162847	48780-1	d6a99b39-3545-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use 144 Initial U.S. Approval: 1996
67046-144-28	2022-01-28	C162847	48780-1	d6a99b39-3545-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use 144 Initial U.S. Approval: 1996
67046-144-30	2022-01-28	C162847	48780-1	d6a99b39-3545-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use 144 Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67046-144-07	donepezil hydrochloride	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	2
67046-144-14	donepezil hydrochloride	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	2
67046-144-15	donepezil hydrochloride	15 in 1 BLISTER PACK	TABLET, FILM COATED	15	2
67046-144-21	donepezil hydrochloride	21 in 1 BLISTER PACK	TABLET, FILM COATED	21	2
67046-144-28	donepezil hydrochloride	28 in 1 BLISTER PACK	TABLET, FILM COATED	28	2
67046-144-30	donepezil hydrochloride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-144	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	2	Legacy NDC, 6 package rows	20181220_598bd4d0-18bc-2542-e053-2991aa0a0762.zip

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
997223	donepezil HCl 10 MG Oral Tablet	PSN	598bd4d0-18bc-2542-e053-2991aa0a0762	2
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	598bd4d0-18bc-2542-e053-2991aa0a0762	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67046-144-21	67046014421	21 TABLET, FILM COATED in 1 BLISTER PACK (67046-144-21)	2017-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
donepezil hydrochloride	Contract Pharmacy Services-PA \| Coupler Enterprises	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL	2