Donepezil

Product NDC: 70518-4380
11-digit product format: 705184380
Labeler code: 70518
Product ID: 70518-4380_5b0ed35a-9262-1c6f-e063-6394a90a01d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA203034
Marketing category: ANDA
Marketing start: 2025-07-01
Substance: DONEPEZIL HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A203034-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2015-01-30
A203034-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2015-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203034-001	AB
A203034-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203034-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203034-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203034-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203034-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203034-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203034-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203034-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203034-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203034-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203034-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203034-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203034-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203034-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203034-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203034-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203034-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203034-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203034-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203034-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203034-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203034-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203034-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203034-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203034-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203034-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203034-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203034-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203034-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203034-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203034-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203034-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203034-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203034-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203034-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203034-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203034-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203034-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203034-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203034-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203034-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Donepezil
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
37fc6638-4a63-4582-a64c-3525f8ed7ef2	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	Strength	SPL version
70518-4380-0	Donepezil	90 in 1 BOTTLE, PLASTIC	TABLET	90		1

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	37fc6638-4a63-4582-a64c-3525f8ed7ef2	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203034 application number: ANDA203034 ndc (product): 70518-4380
Donepezil	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	84d8ca68-26f3-4dd5-9dd4-6a7525a30db1	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203034 application number: ANDA203034
Donepezil	DONEPEZIL HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	c7e1f642-1bdc-4ed6-9b9e-c1af40b926cd	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203034 application number: ANDA203034
Donepezil	DONEPEZIL HYDROCHLORIDE	American Health Packaging	12ae85f0-023c-49ca-8c4a-0a6a7585290e	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203034 application number: ANDA203034
Donepezil	DONEPEZIL HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	11ac01f4-d26e-47b2-9660-d514ab097fdb	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203034 application number: ANDA203034

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	37fc6638-4a63-4582-a64c-3525f8ed7ef2	1
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	37fc6638-4a63-4582-a64c-3525f8ed7ef2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4380-0	70518438000	90 TABLET in 1 BOTTLE, PLASTIC (70518-4380-0)	90 tablet	2025-07-01	No	No	Current