FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
71335-0416
11-digit product format
713350416
Labeler code
71335
Product ID
71335-0416_b3614572-97ec-4396-81ef-8a42cfdc8fec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201146
Marketing category
ANDA
Marketing start
2012-08-17
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
71335-0416-1Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
71335-0416-2Donepezil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
71335-0416-3Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0416-1EA - Each71335-041613e5b23d-ef98-4067-8ca1-bafc2987101312018-03-08
71335-0416-2EA - Each71335-04160c2faad1-7a0d-47bf-8fe1-926706a914e912018-03-08
71335-0416-3EA - Each71335-0416a50dac2d-ba0d-492d-aed6-fd89782ff06f12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0416DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 3 package rows20240417_4747633b-ac32-455e-8d50-ce9c481480c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN4747633b-ac32-455e-8d50-ce9c481480c05
997223donepezil hydrochloride 10 MG Oral TabletSCD4747633b-ac32-455e-8d50-ce9c481480c05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0416-17133504160130 TABLET, FILM COATED in 1 BOTTLE (71335-0416-1) 2020-07-240000-00-00NoNoCurrent
71335-0416-27133504160260 TABLET, FILM COATED in 1 BOTTLE (71335-0416-2) 2024-04-030000-00-00NoNoCurrent
71335-0416-37133504160390 TABLET, FILM COATED in 1 BOTTLE (71335-0416-3) 2021-12-220000-00-00NoNoCurrent