Donepezil Hydrochloride

Product NDC
63629-9326
11-digit product format
636299326
Labeler code
63629
Product ID
63629-9326_d6779abc-44d4-49af-9a8e-d0b94871475c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090056
Marketing category
ANDA
Marketing start
2011-05-31
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 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
63629-9326-16362993260190 TABLET, FILM COATED in 1 BOTTLE (63629-9326-1) 2025-06-05NoNoHistorical
63629-9326-26362993260230 TABLET, FILM COATED in 1 BOTTLE (63629-9326-2) 2025-06-05NoNoHistorical
63629-9326-36362993260360 TABLET, FILM COATED in 1 BOTTLE (63629-9326-3) 2025-06-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Donepezil HydrochlorideBryant Ranch Prepack2025-06-05HUMAN PRESCRIPTION DRUG LABEL1