Donepezil Hydrochloride

Product NDC
71335-2022
11-digit product format
713352022
Labeler code
71335
Product ID
71335-2022_c311f933-2648-4bf4-9328-a8c99ee8e9d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201146
Marketing category
ANDA
Marketing start
2012-08-17
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
71335-2022-1Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90102
71335-2022-2Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30102
71335-2022-3Donepezil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2022DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 3 package rows20240423_aa2c22b8-2dd4-4916-bc4f-9995eab74a6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSNaa2c22b8-2dd4-4916-bc4f-9995eab74a6e102
997229donepezil hydrochloride 5 MG Oral TabletSCDaa2c22b8-2dd4-4916-bc4f-9995eab74a6e102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2022-17133520220190 TABLET, FILM COATED in 1 BOTTLE (71335-2022-1) 2024-04-030000-00-00NoNoCurrent
71335-2022-27133520220230 TABLET, FILM COATED in 1 BOTTLE (71335-2022-2) 2021-12-220000-00-00NoNoCurrent
71335-2022-37133520220360 TABLET, FILM COATED in 1 BOTTLE (71335-2022-3) 2024-04-030000-00-00NoNoCurrent