donepezil hydrochloride

Product NDC: 29300-250
11-digit product format: 293000250
Labeler code: 29300
Product ID: 29300-250_88d3f867-45f4-42fb-93f8-235c2f594760
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: donepezil hydrochloride
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA204831
Marketing category: ANDA
Marketing start: 2016-11-10
Substance: DONEPEZIL HYDROCHLORIDE
Active strength: 5 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204831-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2016-11-10
A204831-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2016-11-10

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	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-11-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204831-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204831-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2016-11-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204831-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204831-002	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A204831-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204831-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204831-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204831-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204831-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204831-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204831-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204831-002	AB	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: donepezil hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DONEPEZIL HYDROCHLORIDE	5 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997220	Internal RxNorm lookup
997223	Internal RxNorm lookup
997226	Internal RxNorm lookup
997229	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
1a8906ce-96dc-4bc8-81c1-5db67a187aac	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7	Product name	1	20221214
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d7e50b51-94ef-29ef-8273-837d555048c1	Product name	9	20160811
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29300-250-11	donepezil hydrochloride	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10		12
29300-250-87	donepezil hydrochloride	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-250-11	EA - Each	29300-250	a5b900d5-3bcd-47c6-93fd-54d3a88e68bd	1	2018-05-09
29300-250-87	EA - Each	29300-250	6571e11c-aec5-40ee-85fb-4619c012d93c	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-250	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [UNICHEM PHARMACEUTICALS (USA), INC.]	11	Current NDC, Legacy NDC, 2 package rows	20201204_1a8906ce-96dc-4bc8-81c1-5db67a187aac.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	Unichem Pharmaceuticals (USA), Inc.	1a8906ce-96dc-4bc8-81c1-5db67a187aac	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204831 application number: ANDA204831 ndc (product): 29300-250

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
997220	donepezil HCl 10 MG Disintegrating Oral Tablet	PSN	1a8906ce-96dc-4bc8-81c1-5db67a187aac	12
997223	donepezil HCl 10 MG Oral Tablet	PSN	1a8906ce-96dc-4bc8-81c1-5db67a187aac	12
997226	donepezil HCl 5 MG Disintegrating Oral Tablet	PSN	1a8906ce-96dc-4bc8-81c1-5db67a187aac	12
997229	donepezil HCl 5 MG Oral Tablet	PSN	1a8906ce-96dc-4bc8-81c1-5db67a187aac	12
997220	donepezil hydrochloride 10 MG Disintegrating Oral Tablet	SCD	1a8906ce-96dc-4bc8-81c1-5db67a187aac	12
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	1a8906ce-96dc-4bc8-81c1-5db67a187aac	12
997226	donepezil hydrochloride 5 MG Disintegrating Oral Tablet	SCD	1a8906ce-96dc-4bc8-81c1-5db67a187aac	12
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	1a8906ce-96dc-4bc8-81c1-5db67a187aac	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-250-11	29300025011	10 in 1 BLISTER PACK						Historical
29300-250-87	29300025087	3 BLISTER PACK in 1 CARTON (29300-250-87) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-250-11)	3 blister pack	2018-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
donepezil hydrochloride	Unichem Pharmaceuticals (USA), Inc.	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	12