FDA.reportPublic FDA data

Donepezil hydrochloride

Product NDC
31722-139
11-digit product format
317220139
Labeler code
31722
Product ID
31722-139_9d688237-1727-46ca-ba3c-efd830b12421
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA203907
Marketing category
ANDA
Marketing start
2016-10-07
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
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
31722-139-102020-01-31C16284748780-19d75b9d0-313c-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These 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 These highlights do not include all the information neededto use DONEPEZIL HYDROCHLORIDE tablets safely and effectively. See fullprescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZILHYDROCHLO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-139-10Donepezil hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-139-10EA - Each31722-1396293494a-d73b-4c84-aa57-b51f0d6b9a9312016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-139DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20161011_9d688237-1727-46ca-ba3c-efd830b12421.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN9d688237-1727-46ca-ba3c-efd830b124211
997229donepezil HCl 5 MG Oral TabletPSN9d688237-1727-46ca-ba3c-efd830b124211
997223donepezil hydrochloride 10 MG Oral TabletSCD9d688237-1727-46ca-ba3c-efd830b124211
997229donepezil hydrochloride 5 MG Oral TabletSCD9d688237-1727-46ca-ba3c-efd830b124211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
31722-139-10317220139101000 in 1 BOTTLEHistorical