FDA.reportPublic FDA data

donepezil hydrochloride

Product NDC
50090-3537
11-digit product format
500903537
Labeler code
50090
Product ID
50090-3537_88e8acb5-251c-442e-bd88-ea7cd0416c6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200292
Marketing category
ANDA
Marketing start
2011-11-01
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997229

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
50090-3537-02023-02-07C16284748780-1f386c649-cb84-0266-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
50090-3537-02023-01-30C16284748780-1f386c649-cb84-0266-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
50090-3537-0donepezil hydrochloride90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3537-0EA - Each50090-35374e3d5c95-a09b-45be-bbc0-c011b95a996e12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3537DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20230208_5d46ef3c-0dee-4389-a2d5-997ea8342817.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSN5d46ef3c-0dee-4389-a2d5-997ea83428177
997229donepezil hydrochloride 5 MG Oral TabletSCD5d46ef3c-0dee-4389-a2d5-997ea83428177

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3537-05009035370090 TABLET, FILM COATED in 1 BOTTLE (50090-3537-0) 2018-08-150000-00-00NoNoCurrent