DONEPEZIL HYDROCHLORIDE

Product NDC
72189-031
11-digit product format
721890031
Labeler code
72189
Product ID
72189-031_2c4e974d-41bb-49ca-e063-6394a90ae3a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DONEPEZIL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA200292
Marketing category
ANDA
Marketing start
2019-10-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-031-602025-01-30C16284748780-12cef2736-90eb-d83d-e063-dadaa90ab31fDONEPEZIL HYDROCHLORIDE
72189-031-902025-01-30C16284748780-12cef2736-5ed6-d83d-e063-dadaa90ab31fDONEPEZIL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-031-30DONEPEZIL HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED303
72189-031-60DONEPEZIL HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601
72189-031-90DONEPEZIL HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-031DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX]3Current NDC, Legacy NDC, 1 package rows20250123_93dddf28-094b-dd8c-e053-2995a90a63e9.zip
72189-031DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20191002_93dd96a4-3a74-ea7e-e053-2a95a90ab0a4.zip
72189-031DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20191002_92fce88e-9fdf-43a8-e053-2995a90a5867.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSN93dddf28-094b-dd8c-e053-2995a90a63e93
997229donepezil hydrochloride 5 MG Oral TabletSCD93dddf28-094b-dd8c-e053-2995a90a63e93
997229donepezil HCl 5 MG Oral TabletPSN92fce88e-9fdf-43a8-e053-2995a90a58671
997229donepezil HCl 5 MG Oral TabletPSN93dd96a4-3a74-ea7e-e053-2a95a90ab0a41
997229donepezil hydrochloride 5 MG Oral TabletSCD92fce88e-9fdf-43a8-e053-2995a90a58671
997229donepezil hydrochloride 5 MG Oral TabletSCD93dd96a4-3a74-ea7e-e053-2a95a90ab0a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-031-307218900313030 TABLET, FILM COATED in 1 BOTTLE (72189-031-30) 2019-10-010000-00-00NoNoCurrent
72189-031-607218900316060 TABLET, FILM COATED in 1 BOTTLE (72189-031-60) 2019-10-010000-00-00NoNoCurrent
72189-031-907218900319090 TABLET, FILM COATED in 1 BOTTLE (72189-031-90) 2019-09-200000-00-00NoNoCurrent