FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
71335-0876
11-digit product format
713350876
Labeler code
71335
Product ID
71335-0876_3ac29f6f-0993-416f-8352-e6c0a5ef3e55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201724
Marketing category
ANDA
Marketing start
2016-01-29
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0876-12024-01-30C16284748780-11030e365-1747-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
71335-0876-22024-01-30C16284748780-11030e365-1747-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
71335-0876-32024-01-30C16284748780-11030e365-1747-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0876-1Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904
71335-0876-2Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
71335-0876-3Donepezil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0876DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]4Legacy NDC, 3 package rows20220202_3ac29f6f-0993-416f-8352-e6c0a5ef3e55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSN3ac29f6f-0993-416f-8352-e6c0a5ef3e554
997229donepezil hydrochloride 5 MG Oral TabletSCD3ac29f6f-0993-416f-8352-e6c0a5ef3e554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0876-17133508760190 TABLET, FILM COATED in 1 BOTTLE (71335-0876-1) 2018-06-220000-00-00NoNoCurrent
71335-0876-27133508760230 TABLET, FILM COATED in 1 BOTTLE (71335-0876-2) 2018-10-230000-00-00NoNoCurrent
71335-0876-37133508760360 TABLET, FILM COATED in 1 BOTTLE (71335-0876-3) 2019-05-100000-00-00NoNoCurrent