Donepezil Hydrochloride

Product NDC
68151-3114
11-digit product format
681513114
Labeler code
68151
Product ID
68151-3114_8525cf49-9c0b-4cfa-8ce2-2ae5170cc146
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA090686
Marketing category
ANDA
Marketing start
2011-05-28
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68151-3114-9Donepezil Hydrochloride1 in 1 PACKAGETABLET, FILM COATED14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-3114DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20160805_4b60c43a-d03c-4661-b865-3636f4527b08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN4b60c43a-d03c-4661-b865-3636f4527b084
997223donepezil hydrochloride 10 MG Oral TabletSCD4b60c43a-d03c-4661-b865-3636f4527b084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-3114-9681513114091 in 1 PACKAGEHistorical