DONEPEZIL HYDROCHLORIDE

Product NDC
24724-029
11-digit product format
247240029
Labeler code
24724
Product ID
24724-029_9e4deae4-c73a-4d5f-94bf-a7ca02a813ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DONEPEZIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
INDICUS PHARMA LLC
Application
ANDA201634
Marketing category
ANDA
Marketing start
2011-06-15
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24724-029DONEPEZIL HYDROCHLORIDE (DONEPEZIL) TABLET, FILM COATED [INDICUS PHARMA LLC]5Legacy NDC20110707_e8ac5d36-8116-456f-8274-3defac54bb24.zip