Donepezil Hydrochloride

Product NDC
63629-8483
11-digit product format
636298483
Labeler code
63629
Product ID
63629-8483_6f78fe1c-7057-41ef-bea2-4f932a842178
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
63629-8483-1Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8483-1EA - Each63629-8483dc67ee79-7b46-4495-8b7a-70ebf54e6a3012021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8483DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240112_caebc31c-5a35-4434-b7e2-80f6405383ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100184donepezil HCl 23 MG Oral TabletPSNcaebc31c-5a35-4434-b7e2-80f6405383ca103
1100184donepezil hydrochloride 23 MG Oral TabletSCDcaebc31c-5a35-4434-b7e2-80f6405383ca103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8483-16362984830130 TABLET, FILM COATED in 1 BOTTLE (63629-8483-1) 2021-05-180000-00-00NoNoCurrent