FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
33261-817
11-digit product format
332610817
Labeler code
33261
Product ID
33261-817_656e9454-b292-4d3a-95d5-157e26365f3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA090425
Marketing category
ANDA
Marketing start
2011-05-31
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-817-302020-01-31C16284748780-19d75b9d0-cd42-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use donepezil hydrochloride tablets USP safely and effectively. See full prescribing information for donepezil hydrochloride tablets USP. DONEPEZIL hydrochloride tablets USP for oral use Initial U.S. Approval: 1996
33261-817-902020-01-31C16284748780-19d75b9d0-cd42-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use donepezil hydrochloride tablets USP safely and effectively. See full prescribing information for donepezil hydrochloride tablets USP. DONEPEZIL hydrochloride tablets USP for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-817-30Donepezil Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
33261-817-90Donepezil Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-817DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140107_25c7ea8c-3c5a-4e09-b746-ee9485443a58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN25c7ea8c-3c5a-4e09-b746-ee9485443a581
997223donepezil hydrochloride 10 MG Oral TabletSCD25c7ea8c-3c5a-4e09-b746-ee9485443a581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-817-303326108173030 in 1 BOTTLE, PLASTICHistorical
33261-817-903326108179090 in 1 BOTTLE, PLASTICHistorical