FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
72162-2136
11-digit product format
721622136
Labeler code
72162
Product ID
72162-2136_b2bf94c3-a8fe-492e-89c4-a4cdb92001a6
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
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
72162-2136-0Donepezil Hydrochloride1000 in 1 BOTTLETABLET1000103
72162-2136-3Donepezil Hydrochloride30 in 1 BOTTLETABLET30103
72162-2136-5Donepezil Hydrochloride500 in 1 BOTTLETABLET500103
72162-2136-9Donepezil Hydrochloride90 in 1 BOTTLETABLET90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2136DONEPEZIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, 4 package rows20241122_385d2fb5-814c-44bd-ac7b-8857d18f144b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSN385d2fb5-814c-44bd-ac7b-8857d18f144b103
997229donepezil hydrochloride 5 MG Oral TabletSCD385d2fb5-814c-44bd-ac7b-8857d18f144b103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2136-0721622136001000 TABLET in 1 BOTTLE (72162-2136-0) 1000 tablet2021-06-29NoNoHistorical
72162-2136-37216221360330 TABLET in 1 BOTTLE (72162-2136-3) 30 tablet2021-06-29NoNoHistorical
72162-2136-572162213605500 TABLET in 1 BOTTLE (72162-2136-5) 500 tablet2021-06-29NoNoHistorical
72162-2136-97216221360990 TABLET in 1 BOTTLE (72162-2136-9) 90 tablet2021-06-29NoNoHistorical