Donepezil Hydrochloride

Product NDC
46708-092
11-digit product format
467080092
Labeler code
46708
Product ID
46708-092_6ca3acff-fe7c-483a-a728-39e06c279dbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA201724
Marketing category
ANDA
Marketing start
2013-03-04
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-092-10Donepezil Hydrochloride5 mg100 in 1 CARTONTABLET, FILM COATED1001
46708-092-30Donepezil Hydrochloride5 mg30 in 1 BOTTLETABLET, FILM COATED301
46708-092-91Donepezil Hydrochloride5 mg1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-092DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1Legacy NDC, 3 package rows20140610_6ca3acff-fe7c-483a-a728-39e06c279dbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN6ca3acff-fe7c-483a-a728-39e06c279dbb1
997229donepezil HCl 5 MG Oral TabletPSN6ca3acff-fe7c-483a-a728-39e06c279dbb1
997223donepezil hydrochloride 10 MG Oral TabletSCD6ca3acff-fe7c-483a-a728-39e06c279dbb1
997229donepezil hydrochloride 5 MG Oral TabletSCD6ca3acff-fe7c-483a-a728-39e06c279dbb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46708-092-1046708009210100 in 1 CARTONHistorical
46708-092-304670800923030 in 1 BOTTLEHistorical
46708-092-91467080092911000 in 1 BOTTLEHistorical