DONEPEZIL HYDROCHLORIDE TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2022-11-05
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 21:49:07

Label at a glance#

Productdonepezil hydrochloride

Active ingredientDONEPEZIL HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-749-01 in bottle of 100 tablets

Donepezil Hydrochloride Tablets USP, 5 mg

R_xonly

100 tablets

NDC 65841-750-01 in bottle of 100 tablets

Donepezil Hydrochloride Tablets USP, 10 mg

R_xonly

100 tablets

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-749	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	5	Legacy NDC	20221109_43a18848-fb43-4adb-9273-a3fe812e3d05.zip
65841-750	DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	5	Legacy NDC	20221109_43a18848-fb43-4adb-9273-a3fe812e3d05.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DONEPEZIL HYDROCHLORIDE	ACTIVE INGREDIENT	3O2T2PJ89D	1
DONEPEZIL	ACTIVE MOIETY	8SSC91326P	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

donepezil hydrochloride
DONEPEZIL
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POLYETHYLENE GLYCOL, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-749	65841-749-05, 65841-749-10, 65841-749-06, 65841-749-16, 65841-749-01, 65841-749-30
65841-750	65841-750-06, 65841-750-16, 65841-750-01, 65841-750-05, 65841-750-10, 65841-750-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DONEPEZIL HYDROCHLORIDE	3O2T2PJ89D	ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
DONEPEZIL HYDROCHLORIDE	3O2T2PJ89D	ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 256 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE / ORAL		3990 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	47.5 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, DELAYED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	POWDER, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	9.5 %w/v		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, EXTENDED RELEASE / ORAL		5364 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	FILM, EXTENDED RELEASE / TRANSDERMAL	19 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED PELLETS / ORAL	14 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	LOTION, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INHALANT / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, COATED PELLETS / ORAL		456 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	POWDER / ORAL		244 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TROCHE / ORAL		300 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	SOLUTION / TOPICAL		200 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, ORALLY DISINTEGRATING / ORAL		4 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE / ORAL		45 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	187.6 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii candidate 27 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A090100-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-10-24
A090100-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090100-001	AB
A090100-002	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	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090100-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090100-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-10-24	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090100-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090100-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090100-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090100-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090100-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090100-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090100-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090100-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090100-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090100-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090100-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090100-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090100-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090100-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090100-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090100-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090100-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090100-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090100-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090100-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090100-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090100-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090100-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090100-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090100-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090100-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090100-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090100-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090100-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090100-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090100-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090100-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090100-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090100-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090100-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090100-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090100-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090100-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090100-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090100-002	AB	1	`4b0b4de00fa7…`

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
90bef7f3-6bf0-4679-8dae-b533bbec6eb0			43a18848-fb43-4adb-9273-a3fe812e3d05	2025-08-14		Exact identifier spl set id: 43a18848-fb43-4adb-9273-a3fe812e3d05

Reported adverse events (FAERS/openFDA)#

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