Donepezil Hydrochloride

Product NDC
72162-1276
11-digit product format
721621276
Labeler code
72162
Product ID
72162-1276_eac36e16-c91d-4435-97dd-089068a3efaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203104
Marketing category
ANDA
Marketing start
2015-03-01
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
23 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 HYDROCHLORIDE23 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui1100184

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
72162-1276-3Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1276-3EA - Each72162-12768b7cc734-c808-4b51-b430-8253c7d1819d12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1276DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240206_8090bff0-e0f0-4846-a2ab-cb28a0a2648d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100184donepezil HCl 23 MG Oral TabletPSN8090bff0-e0f0-4846-a2ab-cb28a0a2648d100
1100184donepezil hydrochloride 23 MG Oral TabletSCD8090bff0-e0f0-4846-a2ab-cb28a0a2648d100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1276-37216212760330 TABLET, FILM COATED in 1 BOTTLE (72162-1276-3) 2024-02-05NoNoCurrent