FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
72162-2137
11-digit product format
721622137
Labeler code
72162
Product ID
72162-2137_693b7fb1-3c85-456b-98ae-67df323703ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078662
Marketing category
ANDA
Marketing start
2021-06-29
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
72162-2137-0Donepezil Hydrochloride1000 in 1 BOTTLETABLET1000102
72162-2137-3Donepezil Hydrochloride30 in 1 BOTTLETABLET30102
72162-2137-5Donepezil Hydrochloride500 in 1 BOTTLETABLET500102
72162-2137-9Donepezil Hydrochloride90 in 1 BOTTLETABLET90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2137DONEPEZIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, 4 package rows20241109_7ab9d0ef-e30c-46e9-9911-435a7b65c47b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN7ab9d0ef-e30c-46e9-9911-435a7b65c47b102
997223donepezil hydrochloride 10 MG Oral TabletSCD7ab9d0ef-e30c-46e9-9911-435a7b65c47b102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2137-0721622137001000 TABLET in 1 BOTTLE (72162-2137-0) 1000 tablet2021-06-29NoNoCurrent
72162-2137-37216221370330 TABLET in 1 BOTTLE (72162-2137-3) 30 tablet2021-06-29NoNoCurrent
72162-2137-572162213705500 TABLET in 1 BOTTLE (72162-2137-5) 500 tablet2021-06-29NoNoCurrent
72162-2137-97216221370990 TABLET in 1 BOTTLE (72162-2137-9) 90 tablet2021-06-29NoNoCurrent