FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
55648-311
11-digit product format
556480311
Labeler code
55648
Product ID
55648-311_63aed8fa-52e1-4e47-91ed-cb7fd6b8cce0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA091267
Marketing category
ANDA
Marketing start
2011-05-28
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
55648-311-012020-01-31C16284748780-19d75b9d0-ee5a-f424-e053-dadaa90a57ceThese 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 Initial U.S. Approval: 1996
55648-311-022020-01-31C16284748780-19d75b9d0-ee5a-f424-e053-dadaa90a57ceThese 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 Initial U.S. Approval: 1996
55648-311-032020-01-31C16284748780-19d75b9d0-ee5a-f424-e053-dadaa90a57ceThese 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 Initial U.S. Approval: 1996
55648-311-042020-01-31C16284748780-19d75b9d0-ee5a-f424-e053-dadaa90a57ceThese 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 Initial U.S. Approval: 1996
55648-311-052020-01-31C16284748780-19d75b9d0-ee5a-f424-e053-dadaa90a57ceThese 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 Initial U.S. Approval: 1996
55648-311-062020-01-31C16284748780-19d75b9d0-ee5a-f424-e053-dadaa90a57ceThese 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 Initial U.S. Approval: 1996
55648-311-072020-01-31C16284748780-19d75b9d0-ee5a-f424-e053-dadaa90a57ceThese 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 Initial U.S. Approval: 1996
55648-311-082020-01-31C16284748780-19d75b9d0-ee5a-f424-e053-dadaa90a57ceThese 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 Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-311-01Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
55648-311-02Donepezil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
55648-311-03Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902
55648-311-04Donepezil Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
55648-311-05Donepezil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10002
55648-311-06Donepezil Hydrochloride100 in 1 CARTONTABLET, FILM COATED1002
55648-311-06Donepezil Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
55648-311-07Donepezil Hydrochloride28 in 1 BOTTLETABLET, FILM COATED282
55648-311-08Donepezil Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-311DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2Legacy NDC, 9 package rows20130611_b7c926f0-8771-41d7-95be-3d4110dc0603.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSNb7c926f0-8771-41d7-95be-3d4110dc06032
997229donepezil HCl 5 MG Oral TabletPSNb7c926f0-8771-41d7-95be-3d4110dc06032
997223donepezil hydrochloride 10 MG Oral TabletSCDb7c926f0-8771-41d7-95be-3d4110dc06032
997229donepezil hydrochloride 5 MG Oral TabletSCDb7c926f0-8771-41d7-95be-3d4110dc06032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-311-015564803110130 in 1 BOTTLEHistorical
55648-311-025564803110260 in 1 BOTTLEHistorical
55648-311-035564803110390 in 1 BOTTLEHistorical
55648-311-0455648031104500 in 1 BOTTLEHistorical
55648-311-05556480311051000 in 1 BOTTLEHistorical
55648-311-0655648031106100 in 1 CARTONHistorical
55648-311-075564803110728 in 1 BOTTLEHistorical
55648-311-0855648031108100 in 1 BOTTLEHistorical