Donepezil Hydrochloride

Product NDC
71335-2093
11-digit product format
713352093
Labeler code
71335
Product ID
71335-2093_280c4887-57c3-4d43-afca-98e64de44219
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090056
Marketing category
ANDA
Marketing start
2011-05-31
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997229

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
71335-2093-1Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90102
71335-2093-2Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30102
71335-2093-3Donepezil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2093DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 3 package rows20240420_c030fd7c-da5c-457a-a825-1767bd87d04d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSNc030fd7c-da5c-457a-a825-1767bd87d04d102
997229donepezil hydrochloride 5 MG Oral TabletSCDc030fd7c-da5c-457a-a825-1767bd87d04d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2093-17133520930190 TABLET, FILM COATED in 1 BOTTLE (71335-2093-1) 2024-04-030000-00-00NoNoCurrent
71335-2093-27133520930230 TABLET, FILM COATED in 1 BOTTLE (71335-2093-2) 2022-05-060000-00-00NoNoCurrent
71335-2093-37133520930360 TABLET, FILM COATED in 1 BOTTLE (71335-2093-3) 2024-04-030000-00-00NoNoCurrent