Donepezil Hydrochloride

Product NDC: 33342-029
Requested package NDC: 33342-029-06
11-digit product format: 333420029
Labeler code: 33342
Product ID: 33342-029_4bf742a3-3c8f-4bd3-b973-54370cbef345
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA201787
Marketing category: ANDA
Marketing start: 2012-12-14
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	33342-029	33342-029-06	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A201787-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14
A201787-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201787-001	AB
A201787-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2012-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201787-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201787-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2012-12-14	`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	A201787-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201787-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201787-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201787-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201787-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201787-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201787-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201787-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201787-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201787-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201787-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201787-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201787-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201787-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201787-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201787-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201787-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201787-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201787-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201787-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201787-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201787-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201787-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201787-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201787-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201787-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201787-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201787-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201787-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201787-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201787-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201787-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201787-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201787-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201787-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201787-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201787-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201787-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201787-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201787-002	AB	1	`782e0a99824c…`

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 · 5 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
1100184	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
06dd25a5-1bf2-446d-ad75-ff9d55117660	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7	Product name	1	20221214
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d7e50b51-94ef-29ef-8273-837d555048c1	Product name	9	20160811
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33342-029-06	Donepezil Hydrochloride	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3	31
33342-029-06	Donepezil Hydrochloride	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	31
33342-029-07	Donepezil Hydrochloride	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	31
33342-029-12	Donepezil Hydrochloride	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	31
33342-029-12	Donepezil Hydrochloride	10 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	10	31
33342-029-60	Donepezil Hydrochloride	4 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	4	31
33342-029-60	Donepezil Hydrochloride	7 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	7	31
33342-029-06	Donepezil Hydrochloride	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	16
33342-029-06	Donepezil Hydrochloride	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3	16
33342-029-07	Donepezil Hydrochloride	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	16
33342-029-12	Donepezil Hydrochloride	10 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	10	16
33342-029-12	Donepezil Hydrochloride	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	16
33342-029-60	Donepezil Hydrochloride	7 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	7	16
33342-029-60	Donepezil Hydrochloride	4 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	4	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-029-07	EA - Each	33342-029	1dc29fe4-50a5-428f-913f-dab1ddeebce8	1	2013-10-17
33342-029-60	EA - Each	33342-029	d6629212-7096-4725-b861-23a5cad9ac54	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DONEPEZIL HYDROCHLORIDE	ACTIVE INGREDIENT	3O2T2PJ89D	DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	31
DONEPEZIL	ACTIVE MOIETY	8SSC91326P	DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	31
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	31
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	31
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	31
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	31
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	31
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	31
DONEPEZIL HYDROCHLORIDE	ACTIVE INGREDIENT	3O2T2PJ89D	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
DONEPEZIL	ACTIVE MOIETY	8SSC91326P	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-029	DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	31	Current NDC, Legacy NDC, 7 package rows	20150901_e1e203cd-fd4c-4046-810b-5d7aea47525e.zip
33342-029	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	16	Current NDC, Legacy NDC, 7 package rows	20230817_06dd25a5-1bf2-446d-ad75-ff9d55117660.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	Macleods Pharmaceuticals Limited	06dd25a5-1bf2-446d-ad75-ff9d55117660	2023-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201787 application number: ANDA201787 ndc (package): 33342-029-06 ndc (product): 33342-029 ndc11 (package): 33342002906

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	e1e203cd-fd4c-4046-810b-5d7aea47525e	31
997226	donepezil HCl 5 MG Disintegrating Oral Tablet	PSN	e1e203cd-fd4c-4046-810b-5d7aea47525e	31
997220	donepezil hydrochloride 10 MG Disintegrating Oral Tablet	SCD	e1e203cd-fd4c-4046-810b-5d7aea47525e	31
997226	donepezil hydrochloride 5 MG Disintegrating Oral Tablet	SCD	e1e203cd-fd4c-4046-810b-5d7aea47525e	31
997220	donepezil HCl 10 MG Disintegrating Oral Tablet	PSN	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
997223	donepezil HCl 10 MG Oral Tablet	PSN	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
1100184	donepezil HCl 23 MG Oral Tablet	PSN	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
997226	donepezil HCl 5 MG Disintegrating Oral Tablet	PSN	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
997229	donepezil HCl 5 MG Oral Tablet	PSN	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
997220	donepezil hydrochloride 10 MG Disintegrating Oral Tablet	SCD	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
1100184	donepezil hydrochloride 23 MG Oral Tablet	SCD	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
997226	donepezil hydrochloride 5 MG Disintegrating Oral Tablet	SCD	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	06dd25a5-1bf2-446d-ad75-ff9d55117660	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-029-06	33342002906	3 BLISTER PACK in 1 CARTON (33342-029-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	3 blister pack	2012-12-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donepezil Hydrochloride	Macleods Pharmaceuticals Limited	2023-08-11	Human Prescription Drug Label	16
Donepezil Hydrochloride	Macleods Pharmaceuticals Limited	2015-08-20	Human Prescription Drug Label	31