FDA.reportPublic FDA data

Donepezil

Product NDC
50090-2627
11-digit product format
500902627
Labeler code
50090
Product ID
50090-2627_1eda014d-ec3c-4940-a6a2-3dfe24b07712
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203034
Marketing category
ANDA
Marketing start
2015-02-02
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil
Listing expiration
2027-12-31

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
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2627-02023-02-07C16284748780-1f386c64a-3601-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
50090-2627-02023-01-30C16284748780-1f386c64a-3601-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2627-0Donepezil90 in 1 BOTTLETABLET9026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2627-0EA - Each50090-26273fa3a03c-554d-4d44-977b-bda06cc1108a12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2627DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 1 package rows20230208_84d8ca68-26f3-4dd5-9dd4-6a7525a30db1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN84d8ca68-26f3-4dd5-9dd4-6a7525a30db126
997229donepezil HCl 5 MG Oral TabletPSN84d8ca68-26f3-4dd5-9dd4-6a7525a30db126
997223donepezil hydrochloride 10 MG Oral TabletSCD84d8ca68-26f3-4dd5-9dd4-6a7525a30db126
997229donepezil hydrochloride 5 MG Oral TabletSCD84d8ca68-26f3-4dd5-9dd4-6a7525a30db126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2627-05009026270090 TABLET in 1 BOTTLE (50090-2627-0) 90 tablet2016-11-170000-00-00NoNoCurrent