DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:48:25

Label at a glance#

Productdonepezil hydrochloride
Active ingredientDONEPEZIL HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-721-06 in bottle of 30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets USP, 5 mg

Rx only

30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets, 5 mg
Donepezil Hydrochloride Orally Disintegrating Tablets, 5 mg

NDC 65841-722-06 in bottle of 30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets USP, 10 mg

Rx only

30 tablets

Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg
Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89D1
DONEPEZILACTIVE MOIETY8SSC91326P1
CROSPOVIDONEINACTIVE INGREDIENT68401960MK1
GLYCYRRHIZIN, AMMONIATEDINACTIVE INGREDIENT3VRD35U26C1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MANNITOLINACTIVE INGREDIENT3OWL53L36A1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2B1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81V1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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 3 · 180 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
STRAWBERRYSTRAWBERRY4J2TY8Y81VSOLUTION / ORAL6 mgExact identifier — unii candidate
5 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / ORAL869 mgExact identifier — unii candidate
65 equally ranked IID candidates
STRAWBERRYSTRAWBERRY4J2TY8Y81VSYRUP / ORAL2.5 mg/5mlExact identifier — unii candidate
5 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC4.35 %w/wExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACONCENTRATE / INTRAVENOUS220 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, DELAYED RELEASE / ORAL639 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGUM, CHEWING / BUCCAL891 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION, CONCENTRATE / INTRAVENOUS220 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / INTRAMUSCULAR6.75 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / SUBLINGUAL495 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, DELAYED RELEASE / ORAL2043 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, EXTENDED RELEASE / ORAL1086 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAVENOUS15200 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE, FOR SUSPENSION / ORAL6000 mgExact identifier — unii candidate
65 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR113 mgExact identifier — unii candidate
65 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
STRAWBERRYSTRAWBERRY4J2TY8Y81VTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
5 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SOLUTION / ORAL3767 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / OPHTHALMIC3.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / ORAL7093 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGEL / OPHTHALMIC25 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
22 equally ranked IID candidates
STRAWBERRYSTRAWBERRY4J2TY8Y81VPOWDER, FOR SUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
5 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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090175-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10
A090175-002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1084e616aacf4f…
2026-09-14 22:38:342026-08A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1084e616aacf4f…
2026-08-18 06:07:402026-07A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090175-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090175-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1074a2ff9319b5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
567c0dd3-5ec9-4584-857a-8f5e7ee64468adb67d38-99f4-44ea-b2c2-b472be7bafc72025-04-02Exact identifier
spl set id: adb67d38-99f4-44ea-b2c2-b472be7bafc7

Reported adverse events (FAERS/openFDA)#

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