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 Rx Only Initial U.S. Approval: 1996
Approved
Approval ID
76bf638e-dbde-418e-8977-1caf009990bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2022
Manufacturers
FDA
Torrent Pharmaceuticals Limited
DUNS: 916488547
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
NDC Product Code13668-103
Application NumberANDA090686
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 25, 2022
Generic NameDonepezil Hydrochloride
INGREDIENTS (11)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
Donepezil Hydrochloride
PRODUCT DETAILS
NDC Product Code13668-102
Application NumberANDA090686
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 25, 2022
Generic NameDonepezil Hydrochloride
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB