Donepezil Hydrochloride

Product NDC
71335-2436
11-digit product format
713352436
Labeler code
71335
Product ID
71335-2436_255eaadf-bf5d-45d2-ac99-906d14d655c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078662
Marketing category
ANDA
Marketing start
2021-06-29
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997223

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2436-1Donepezil Hydrochloride30 in 1 BOTTLETABLET301
71335-2436-2Donepezil Hydrochloride60 in 1 BOTTLETABLET601
71335-2436-3Donepezil Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2436DONEPEZIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1Current NDC, 3 package rows20240719_7db089de-0344-4246-81b7-7c88a2a18402.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN7db089de-0344-4246-81b7-7c88a2a184021
997223donepezil hydrochloride 10 MG Oral TabletSCD7db089de-0344-4246-81b7-7c88a2a184021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2436-17133524360130 TABLET in 1 BOTTLE (71335-2436-1) 30 tablet2024-07-15NoNoHistorical
71335-2436-27133524360260 TABLET in 1 BOTTLE (71335-2436-2) 60 tablet2024-07-15NoNoHistorical
71335-2436-37133524360390 TABLET in 1 BOTTLE (71335-2436-3) 90 tablet2024-07-15NoNoHistorical