Donepezil Hydrochloride

Product NDC: 65862-325
Requested package NDC: 65862-325-59
11-digit product format: 658620325
Labeler code: 65862
Product ID: 65862-325_3c956648-d46c-41e2-a2d9-8560846a7a32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090056
Marketing category: ANDA
Marketing start: 2011-05-31
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
unfinished package	package	65862-325	65862-325-59	UNFINISHED	Active or certified unfinished drug listing		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 · 21 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A090056-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-05-31
A090056-002	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
A090056-001	AB
A090056-002	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	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090056-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090056-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090056-002	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	A090056-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090056-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090056-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090056-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090056-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090056-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090056-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090056-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090056-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090056-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090056-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090056-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090056-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090056-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090056-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090056-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090056-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090056-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090056-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090056-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090056-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090056-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090056-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090056-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090056-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090056-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090056-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090056-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090056-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090056-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090056-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090056-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090056-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090056-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090056-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090056-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090056-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090056-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090056-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090056-002	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997223	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
3257494f-8f44-4978-b92d-bde87b2444b6	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
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7	Product name	1	20221214
d7e50b51-94ef-29ef-8273-837d555048c1	Product name	9	20160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-325-01	Donepezil Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
65862-325-05	Donepezil Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	11
65862-325-10	Donepezil Hydrochloride	10 in 1 CARTON	TABLET, FILM COATED	10	11
65862-325-10	Donepezil Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	11
65862-325-30	Donepezil Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	11
65862-325-90	Donepezil Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	11
65862-325-99	Donepezil Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-325-30	EA - Each	65862-325	c4149761-0994-4d9a-ab8a-d26c2a5ccc1b	1	2012-07-24
65862-325-90	EA - Each	65862-325	03a3a5d5-d081-423a-aa0d-65c72709d860	1	2012-07-24
65862-325-99	EA - Each	65862-325	72ef6bfa-3ef4-4c25-8727-728d576984f7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DONEPEZIL HYDROCHLORIDE	ACTIVE INGREDIENT	3O2T2PJ89D	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
DONEPEZIL	ACTIVE MOIETY	8SSC91326P	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-325	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	11	Current NDC, Legacy NDC, 7 package rows	20240109_3257494f-8f44-4978-b92d-bde87b2444b6.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8138f616-83f3-4c47-84ef-1bce2db339f7	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	de96349a-5fee-4de9-921c-e453d44b3203	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	e2ab403a-ec2d-44e7-9da1-66d0a7443f1d	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Coupler LLC	2d01fb96-c825-fad5-e063-6394a90ac6cc	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	0516d548-db9b-410a-aec9-79aedbc3f6e9	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	c030fd7c-da5c-457a-a825-1767bd87d04d	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Aurobindo Pharma Limited	3257494f-8f44-4978-b92d-bde87b2444b6	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056 ndc (product): 65862-325
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Rising Pharma Holdings, Inc.	86b0c5a0-ff3c-4840-a4ac-82af922d58bf	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090056 application number: ANDA090056

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	3257494f-8f44-4978-b92d-bde87b2444b6	11
997229	donepezil HCl 5 MG Oral Tablet	PSN	3257494f-8f44-4978-b92d-bde87b2444b6	11
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	3257494f-8f44-4978-b92d-bde87b2444b6	11
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	3257494f-8f44-4978-b92d-bde87b2444b6	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-325-59	65862032559	5000 TABLET, FILM COATED in 1 BAG (65862-325-59)	31-MAY-11	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donepezil Hydrochloride	Aurobindo Pharma Limited \| Aurolife Pharma LLC	2024-01-08	Human Prescription Drug Label	11