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 Initial U.S. Approval: 1996
Approved
Approval ID
297e86e8-d248-4cc9-9d9c-2ef9efb4414d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2023
Manufacturers
FDA
ACI Healthcare USA, Inc.
DUNS: 080430318
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 Code71093-128
Application NumberANDA078662
Product Classification
M
Marketing Category
C73584
G
Generic Name
Donepezil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Donepezil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71093-127
Application NumberANDA078662
Product Classification
M
Marketing Category
C73584
G
Generic Name
Donepezil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT