Donepezil Hydrochloride

Product NDC
67046-134
11-digit product format
670460134
Labeler code
67046
Product ID
67046-134_ec5cc9e9-aa3a-4c54-b0a1-de1449701f78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA090686
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
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-134-30Donepezil Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-134DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20111006_ec5cc9e9-aa3a-4c54-b0a1-de1449701f78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSNec5cc9e9-aa3a-4c54-b0a1-de1449701f781
997229donepezil HCl 5 MG Oral TabletPSNec5cc9e9-aa3a-4c54-b0a1-de1449701f781
997223donepezil hydrochloride 10 MG Oral TabletSCDec5cc9e9-aa3a-4c54-b0a1-de1449701f781
997229donepezil hydrochloride 5 MG Oral TabletSCDec5cc9e9-aa3a-4c54-b0a1-de1449701f781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-134-306704601343030 in 1 BLISTER PACKHistorical