Donepezil Hydrochloride
These highlights do not include all the information needed to use Donepezil Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Donepezil Hydrochloride Tablets, USP. Donepezil Hydrochloride Tablets USP, for oral useInitial U.S. Approval: 1996
Approved
Approval ID
cb1809d4-5f84-46bc-830a-f71e8c45bc80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2018
Manufacturers
FDA
BIOMES PHARMACEUTICALS LLC
DUNS: 078644310
Products 2
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 Code69150-416
Application NumberANDA090551
Product Classification
M
Marketing Category
C73584
G
Generic Name
donepezil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2018
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
donepezil hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69150-415
Application NumberANDA090551
Product Classification
M
Marketing Category
C73584
G
Generic Name
donepezil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2018
FDA Product Classification
INGREDIENTS (9)
DONEPEZIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT