Donepezil Hydrochloride

Product NDC
71335-2346
11-digit product format
713352346
Labeler code
71335
Product ID
71335-2346_d51b7603-3e3f-470a-bece-b81e13dab4fd
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2346-1Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30100
71335-2346-2Donepezil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60100
71335-2346-3Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2346DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20240207_1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55100
997223donepezil hydrochloride 10 MG Oral TabletSCD1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2346-17133523460130 TABLET, FILM COATED in 1 BOTTLE (71335-2346-1) 2024-02-06NoNoHistorical
71335-2346-27133523460260 TABLET, FILM COATED in 1 BOTTLE (71335-2346-2) 2024-02-06NoNoHistorical
71335-2346-37133523460390 TABLET, FILM COATED in 1 BOTTLE (71335-2346-3) 2024-02-06NoNoHistorical