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,5 mg and 10 mg Initial U.S. Approval: 1996
Approved
Approval ID
e8ac5d36-8116-456f-8274-3defac54bb24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 7, 2011
Manufacturers
FDA
INDICUS PHARMA LLC
DUNS: 793870606
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DONEPEZIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24724-028
Application NumberANDA201634
Product Classification
M
Marketing Category
C73584
G
Generic Name
DONEPEZIL
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2011
FDA Product Classification
INGREDIENTS (9)
DONEPEZIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DONEPEZIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24724-029
Application NumberANDA201634
Product Classification
M
Marketing Category
C73584
G
Generic Name
DONEPEZIL
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2011
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT