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 Initial U.S. Approval: 1996
Approved
Approval ID
e08dc0ab-3c86-43d4-ab18-ce4212657484
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2011
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
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 Code67046-128
Application NumberNDA020690
Product Classification
M
Marketing Category
C73594
G
Generic Name
Donepezil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2010
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Donepezil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-129
Application NumberNDA020690
Product Classification
M
Marketing Category
C73594
G
Generic Name
Donepezil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2010
FDA Product Classification
INGREDIENTS (11)
DONEPEZIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT