DONEPEZIL HYDROCHLORIDE

Product NDC
72189-265
11-digit product format
721890265
Labeler code
72189
Product ID
72189-265_2c290521-043d-e9df-e063-6294a90a4ed8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DONEPEZIL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRx
Application
ANDA200292
Marketing category
ANDA
Marketing start
2021-09-03
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997223

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
72189-265-90DONEPEZIL HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-265DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DIRECTRX]2Current NDC, Legacy NDC, 1 package rows20250121_cb1b3ed1-6e68-08e2-e053-2995a90a68c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSNcb1b3ed1-6e68-08e2-e053-2995a90a68c42
997223donepezil hydrochloride 10 MG Oral TabletSCDcb1b3ed1-6e68-08e2-e053-2995a90a68c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-265-907218902659090 TABLET, FILM COATED in 1 BOTTLE (72189-265-90) 2021-09-030000-00-00NoNoCurrent