FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
59115-110
11-digit product format
591150110
Labeler code
59115
Product ID
59115-110_f1107c54-e3b7-4380-b405-46ea96687a7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hikma Pharmaceutical
Application
ANDA090247
Marketing category
ANDA
Marketing start
2011-05-28
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
A090247-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31
A090247-002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31

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 22:38:342026-08A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-3184e616aacf4f…
2026-09-14 22:38:342026-08A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-3184e616aacf4f…
2026-08-18 06:07:402026-07A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090247-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090247-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-3174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIEDINACTIVE INGREDIENTQG4MW19XYXDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]4