donepezil hydrochloride

Product NDC: 68071-1700
Requested package NDC: 68071-1700-9
11-digit product format: 680711700
Labeler code: 68071
Product ID: 68071-1700_bb127819-f1de-e702-e053-2a95a90a2028
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: donepezil hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA200292
Marketing category: ANDA
Marketing start: 2011-11-01
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: 2022-12-31
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	68071-1700	68071-1700-9	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 · 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 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	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200292-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200292-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	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…`

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	A200292-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200292-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200292-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200292-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200292-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200292-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200292-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200292-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200292-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200292-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200292-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200292-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200292-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200292-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200292-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200292-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200292-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200292-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200292-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200292-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200292-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200292-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200292-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1700-9	2024-08-21	C162847	48780-1	ba0f9c33-2659-a910-e053-dadaa90a0b85	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 Initial U.S. Approval: 1996
68071-1700-9	2023-01-30	C162847	48780-1	ba0f9c33-2659-a910-e053-dadaa90a0b85	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 Initial U.S. Approval: 1996
68071-1700-9	2021-02-11	C162847	48780-1	ba0f9c33-2659-a910-e053-dadaa90a0b85	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 Initial U.S. Approval: 1996
68071-1700-9	2021-01-29	C162847	48780-1	ba0f9c33-2659-a910-e053-dadaa90a0b85	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 Initial U.S. Approval: 1996

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
68071-1700-9	68071170009	90 TABLET, FILM COATED in 1 BOTTLE (68071-1700-9)	2018-07-13	0000-00-00	No	No	Current