Donepezil

Product NDC
60687-303
11-digit product format
606870303
Labeler code
60687
Product ID
60687-303_3f922a89-21fe-d605-e063-6294a90a8b8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203034
Marketing category
ANDA
Marketing start
2017-03-21
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997223, 997229

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-303-01Donepezil100 in 1 BOX, UNIT-DOSETABLET1007
60687-303-11Donepezil1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-303-01EA - Each60687-3030fe38acb-4339-4c07-b592-323ef94451f712017-04-05
60687-303-11EA - Each60687-3033e25814f-70f8-4d07-bba7-7fb09bbe1e7e12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-303DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20240927_12ae85f0-023c-49ca-8c4a-0a6a7585290e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN12ae85f0-023c-49ca-8c4a-0a6a7585290e7
997229donepezil HCl 5 MG Oral TabletPSN12ae85f0-023c-49ca-8c4a-0a6a7585290e7
997223donepezil hydrochloride 10 MG Oral TabletSCD12ae85f0-023c-49ca-8c4a-0a6a7585290e7
997229donepezil hydrochloride 5 MG Oral TabletSCD12ae85f0-023c-49ca-8c4a-0a6a7585290e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-303-0160687030301100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-303-01) / 1 TABLET in 1 BLISTER PACK (60687-303-11) 100 blister pack2017-03-210000-00-00NoNoCurrent
60687-303-11606870303111 in 1 BLISTER PACKHistorical