Donepezil Hydrochloride

Product NDC: 33342-027
11-digit product format: 333420027
Labeler code: 33342
Product ID: 33342-027_4bf742a3-3c8f-4bd3-b973-54370cbef345
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA201146
Marketing category: ANDA
Marketing start: 2012-08-17
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 42.

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 · 84 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
2026-08-18 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…`
2019-12-13 00:20 UTC	2019-12	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201146-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201146-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201146-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201146-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201146-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201146-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201146-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201146-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201146-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201146-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201146-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201146-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201146-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201146-002	AB	1	`4b0b4de00fa7…`
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…`

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
33342-027-07	Donepezil Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	16
33342-027-10	Donepezil Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	16
33342-027-12	Donepezil Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	16
33342-027-12	Donepezil Hydrochloride	10 in 1 CARTON	TABLET, FILM COATED	10	16
33342-027-15	Donepezil Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	16
33342-027-31	Donepezil Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	16
33342-027-31	Donepezil Hydrochloride	5 in 1 CARTON	TABLET, FILM COATED	5	16
33342-027-44	Donepezil Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-027-07	EA - Each	33342-027	fc408102-8a44-4d0e-9998-69b59d2b10c1	1	2013-07-02
33342-027-10	EA - Each	33342-027	ee0dbb69-2ec9-4f61-a439-32e5adaf0d3a	1	2013-07-02
33342-027-15	EA - Each	33342-027	7d8cd44d-4916-4d29-b826-a6f1e02aca95	1	2014-08-01
33342-027-44	EA - Each	33342-027	92d56d63-20a6-4cd8-8956-8349f6395ef0	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
33342-027	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]	16	Current NDC, Legacy NDC, 8 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 · 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 ndc (product): 33342-027
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
997229	donepezil HCl 5 MG Oral Tablet	PSN	aa2c22b8-2dd4-4916-bc4f-9995eab74a6e	102
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	aa2c22b8-2dd4-4916-bc4f-9995eab74a6e	102
997220	donepezil HCl 10 MG Disintegrating Oral Tablet	PSN	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
997223	donepezil HCl 10 MG Oral Tablet	PSN	ac857917-74db-4591-be9f-d1c822c68c81	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
997229	donepezil HCl 5 MG Oral Tablet	PSN	ac857917-74db-4591-be9f-d1c822c68c81	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
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	ac857917-74db-4591-be9f-d1c822c68c81	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	ac857917-74db-4591-be9f-d1c822c68c81	16
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	06dd25a5-1bf2-446d-ad75-ff9d55117660	16
997229	donepezil HCl 5 MG Oral Tablet	PSN	0c6b12e8-1933-40d8-bf43-97339b2b54fb	1
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	0c6b12e8-1933-40d8-bf43-97339b2b54fb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-027-07	33342002707	30 TABLET, FILM COATED in 1 BOTTLE (33342-027-07)		2012-08-17	0000-00-00	No	No	Current
33342-027-10	33342002710	90 TABLET, FILM COATED in 1 BOTTLE (33342-027-10)		2012-08-17	0000-00-00	No	No	Current
33342-027-12	33342002712	10 BLISTER PACK in 1 CARTON (33342-027-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2012-08-17	0000-00-00	No	No	Current
33342-027-15	33342002715	500 TABLET, FILM COATED in 1 BOTTLE (33342-027-15)		2014-11-06	0000-00-00	No	No	Current
33342-027-31	33342002731	5 BLISTER PACK in 1 CARTON (33342-027-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK	5 blister pack	2012-08-17	0000-00-00	No	No	Current
33342-027-44	33342002744	1000 TABLET, FILM COATED in 1 BOTTLE (33342-027-44)		2014-11-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donepezil Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	16
Donepezil Hydrochloride	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	102
Donepezil Hydrochloride	Macleods Pharmaceuticals Limited	2023-08-11	Human Prescription Drug Label	16
Donepezil Hydrochloride	A-S Medication Solutions	2023-01-18	Human Prescription Drug Label	1