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

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997229

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9326-1Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
63629-9326-2Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
63629-9326-3Donepezil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSNe2ab403a-ec2d-44e7-9da1-66d0a7443f1d1
997229donepezil hydrochloride 5 MG Oral TabletSCDe2ab403a-ec2d-44e7-9da1-66d0a7443f1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-9326-16362993260190 TABLET, FILM COATED in 1 BOTTLE (63629-9326-1) 2025-06-05NoNoCurrent
63629-9326-26362993260230 TABLET, FILM COATED in 1 BOTTLE (63629-9326-2) 2025-06-05NoNoCurrent
63629-9326-36362993260360 TABLET, FILM COATED in 1 BOTTLE (63629-9326-3) 2025-06-05NoNoCurrent