Donepezil Hydrochloride

Product NDC
63629-8483
11-digit product format
636298483
Labeler code
63629
Product ID
63629-8483_6f78fe1c-7057-41ef-bea2-4f932a842178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203104
Marketing category
ANDA
Marketing start
2015-03-01
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
23 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
3O2T2PJ89DDONEPEZIL HYDROCHLORIDE120011-70-3DONEPEZIL HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-8483-16362984830130 TABLET, FILM COATED in 1 BOTTLE (63629-8483-1) 2021-05-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Donepezil HydrochlorideBryant Ranch Prepack2024-01-11HUMAN PRESCRIPTION DRUG LABEL103