Donepezil

Product NDC: 31722-737
11-digit product format: 317220737
Labeler code: 31722
Product ID: 31722-737_2b1d0795-adc8-39e4-e063-6294a90a91cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Donepezil hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA203034
Marketing category: ANDA
Marketing start: 2015-02-02
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
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 · 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	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…`
2019-12-13 00:20 UTC	2019-12	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203034-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-01-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203034-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-01-30	`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	A203034-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203034-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203034-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203034-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203034-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203034-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203034-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203034-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203034-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203034-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203034-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203034-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203034-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203034-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203034-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203034-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203034-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203034-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203034-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203034-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203034-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203034-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203034-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203034-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203034-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203034-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203034-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203034-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203034-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203034-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203034-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203034-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203034-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203034-002	AB	1	`4b0b4de00fa7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Donepezil
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
11ac01f4-d26e-47b2-9660-d514ab097fdb	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7	Product name	1	20221214
d7e50b51-94ef-29ef-8273-837d555048c1	Product name	9	20160811

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
31722-737-01	2020-02-06	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
31722-737-05	2020-02-06	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
31722-737-30	2020-02-06	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
31722-737-31	2020-02-06	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
31722-737-90	2020-02-06	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
31722-737-01	2020-01-31	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
31722-737-05	2020-01-31	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
31722-737-30	2020-01-31	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
31722-737-31	2020-01-31	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
31722-737-90	2020-01-31	These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-737-01	Donepezil	100 in 1 BOTTLE	TABLET	100	6
31722-737-05	Donepezil	500 in 1 BOTTLE	TABLET	500	6
31722-737-30	Donepezil	30 in 1 BOTTLE	TABLET	30	6
31722-737-31	Donepezil	100 in 1 BLISTER PACK	TABLET	100	6
31722-737-90	Donepezil	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-737-05	EA - Each	31722-737	a8902fb3-5b5e-41ea-ada5-4000a982b992	1	2016-11-08
31722-737-30	EA - Each	31722-737	e888e63c-9aa6-4dfe-9dee-f8fad4976986	1	2015-10-02
31722-737-90	EA - Each	31722-737	79f6720c-227f-4217-883c-65d5a8896689	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DONEPEZIL HYDROCHLORIDE	ACTIVE INGREDIENT	3O2T2PJ89D	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
DONEPEZIL	ACTIVE MOIETY	8SSC91326P	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-737	DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 5 package rows	20250109_11ac01f4-d26e-47b2-9660-d514ab097fdb.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	37fc6638-4a63-4582-a64c-3525f8ed7ef2	2025-07-02	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 ndc (product): 31722-737

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	84d8ca68-26f3-4dd5-9dd4-6a7525a30db1	26
997229	donepezil HCl 5 MG Oral Tablet	PSN	84d8ca68-26f3-4dd5-9dd4-6a7525a30db1	26
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	84d8ca68-26f3-4dd5-9dd4-6a7525a30db1	26
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	84d8ca68-26f3-4dd5-9dd4-6a7525a30db1	26
997223	donepezil HCl 10 MG Oral Tablet	PSN	12ae85f0-023c-49ca-8c4a-0a6a7585290e	7
997229	donepezil HCl 5 MG Oral Tablet	PSN	12ae85f0-023c-49ca-8c4a-0a6a7585290e	7
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	12ae85f0-023c-49ca-8c4a-0a6a7585290e	7
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	12ae85f0-023c-49ca-8c4a-0a6a7585290e	7
997223	donepezil HCl 10 MG Oral Tablet	PSN	11ac01f4-d26e-47b2-9660-d514ab097fdb	6
997229	donepezil HCl 5 MG Oral Tablet	PSN	11ac01f4-d26e-47b2-9660-d514ab097fdb	6
997223	donepezil hydrochloride 10 MG Oral Tablet	SCD	11ac01f4-d26e-47b2-9660-d514ab097fdb	6
997229	donepezil hydrochloride 5 MG Oral Tablet	SCD	11ac01f4-d26e-47b2-9660-d514ab097fdb	6
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	Marketing end	Sample	Exclude flag	Status
31722-737-01	31722073701	100 TABLET in 1 BOTTLE (31722-737-01)	100 tablet	2015-02-02	0000-00-00	No	No	Current
31722-737-05	31722073705	500 TABLET in 1 BOTTLE (31722-737-05)	500 tablet	2015-02-02	0000-00-00	No	No	Current
31722-737-30	31722073730	30 TABLET in 1 BOTTLE (31722-737-30)	30 tablet	2015-02-02	0000-00-00	No	No	Current
31722-737-31	31722073731	100 TABLET in 1 BLISTER PACK (31722-737-31)	100 tablet	2015-02-02	0000-00-00	No	No	Current
31722-737-90	31722073790	90 TABLET in 1 BOTTLE (31722-737-90)	90 tablet	2015-02-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donepezil	A-S Medication Solutions	2026-01-20	HUMAN PRESCRIPTION DRUG LABEL	26
Donepezil	American Health Packaging	2025-09-24	HUMAN PRESCRIPTION DRUG LABEL	7
Donepezil	REMEDYREPACK INC.	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
Donepezil	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit V	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	6
Donepezil	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	3
Donepezil	Preferred Pharmaceuticals Inc.	2020-03-06	HUMAN PRESCRIPTION DRUG LABEL	1
Donepezil	NuCare Pharmaceuticals, Inc.	2017-06-16	HUMAN PRESCRIPTION DRUG LABEL	1
Donepezil	NuCarePharmaceuticals, Inc. \| NuCare Pharmaceuticals, Inc.	2017-06-14	HUMAN PRESCRIPTION DRUG LABEL	1