Donepezil Hydrochloride
These 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, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
04498589-1cbb-4008-80ce-f9f1ac57eb86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2017
Manufacturers
FDA
Dexcel Pharma Technologies Ltd.
DUNS: 533597626
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Donepezil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64239-404
Application NumberANDA203713
Product Classification
M
Marketing Category
C73584
G
Generic Name
Donepezil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2017
FDA Product Classification
INGREDIENTS (14)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 23 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT