Donepezil Hydrochloride
Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996
Approved
Approval ID
caebc31c-5a35-4434-b7e2-80f6405383ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-8483
Application NumberANDA203104
Product Classification
M
Marketing Category
C73584
G
Generic Name
Donepezil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2022
FDA Product Classification
INGREDIENTS (14)
DONEPEZIL HYDROCHLORIDEActive
Quantity: 23 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT