Donepezil Hydrochloride

Product NDC
64239-404
11-digit product format
642390404
Labeler code
64239
Product ID
64239-404_4881001c-c215-2033-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dexcel Pharma Technologies Ltd.
Application
ANDA203713
Marketing category
ANDA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
23 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64239-404-03Donepezil Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306
64239-404-10Donepezil Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006
64239-404-50Donepezil Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64239-404DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DEXCEL PHARMA TECHNOLOGIES LTD.]6Legacy NDC, 3 package rows20170214_04498589-1cbb-4008-80ce-f9f1ac57eb86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100184donepezil HCl 23 MG Oral TabletPSN04498589-1cbb-4008-80ce-f9f1ac57eb866
1100184donepezil hydrochloride 23 MG Oral TabletSCD04498589-1cbb-4008-80ce-f9f1ac57eb866

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64239-404-036423904040330 in 1 BOTTLE, PLASTICHistorical
64239-404-1064239040410100 in 1 BOTTLE, PLASTICHistorical
64239-404-5064239040450500 in 1 BOTTLE, PLASTICHistorical