Donepezil Hydrochloride

Product NDC
71335-2065
11-digit product format
713352065
Labeler code
71335
Product ID
71335-2065_21beae45-cb33-4b93-8343-15dbb3c59977
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
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
71335-2065-1Donepezil Hydrochloride90 in 1 BOTTLETABLET90104
71335-2065-2Donepezil Hydrochloride30 in 1 BOTTLETABLET30104
71335-2065-3Donepezil Hydrochloride60 in 1 BOTTLETABLET60104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2065DONEPEZIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 3 package rows20240420_ecf91436-9de1-44bb-8366-8551479c86a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSNecf91436-9de1-44bb-8366-8551479c86a9104
997229donepezil hydrochloride 5 MG Oral TabletSCDecf91436-9de1-44bb-8366-8551479c86a9104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2065-17133520650190 TABLET in 1 BOTTLE (71335-2065-1) 90 tablet2024-04-030000-00-00NoNoCurrent
71335-2065-27133520650230 TABLET in 1 BOTTLE (71335-2065-2) 30 tablet2023-10-190000-00-00NoNoCurrent
71335-2065-37133520650360 TABLET in 1 BOTTLE (71335-2065-3) 60 tablet2024-04-030000-00-00NoNoCurrent