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, for oral use . Initial U.S. Approval: pending
Approved
Approval ID
3099650a-157f-4ef9-8087-22f15699846a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2019
Manufacturers
FDA
Hisun Pharmaceuticals USA, Inc.
DUNS: 961628505
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 Code42658-130
Application NumberANDA202410
Product Classification
M
Marketing Category
C73584
G
Generic Name
Donepezil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2019
FDA Product Classification
INGREDIENTS (16)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 23 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB