FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
68554-5038
11-digit product format
685545038
Labeler code
68554
Product ID
68554-5038_80cddc08-045b-4321-9e90-e3a649561378
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hetero Labs Limited
Application
ANDA203034
Marketing category
ANDA
Marketing start
2014-09-02
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
68554-5038-02021-01-29C16284748780-1ba0f9c33-2024-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets USP, for oral use Initial U.S. Approval: 1996
68554-5038-12021-01-29C16284748780-1ba0f9c33-2024-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets USP, for oral use Initial U.S. Approval: 1996
68554-5038-22021-01-29C16284748780-1ba0f9c33-2024-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets USP, for oral use Initial U.S. Approval: 1996
68554-5038-32021-01-29C16284748780-1ba0f9c33-2024-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets USP, for oral use Initial U.S. Approval: 1996
68554-5038-42021-01-29C16284748780-1ba0f9c33-2024-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets USP, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68554-5038-0Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
68554-5038-1Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903
68554-5038-2Donepezil Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003
68554-5038-3Donepezil Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5003
68554-5038-4Donepezil Hydrochloride10 in 1 CARTONTABLET, FILM COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68554-5038DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HETERO LABS LIMITED]3Legacy NDC, 5 package rows20191127_7a3e16be-8836-4cc8-8957-39232f9975e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN7a3e16be-8836-4cc8-8957-39232f9975e63
997229donepezil HCl 5 MG Oral TabletPSN7a3e16be-8836-4cc8-8957-39232f9975e63
997223donepezil hydrochloride 10 MG Oral TabletSCD7a3e16be-8836-4cc8-8957-39232f9975e63
997229donepezil hydrochloride 5 MG Oral TabletSCD7a3e16be-8836-4cc8-8957-39232f9975e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68554-5038-06855450380030 in 1 BOTTLEHistorical
68554-5038-16855450380190 in 1 BOTTLEHistorical
68554-5038-268554503802100 in 1 BOTTLEHistorical
68554-5038-368554503803500 in 1 BOTTLEHistorical
68554-5038-46855450380410 in 1 CARTONHistorical