Donepezil Hydrochloride
These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS. DONEPEZIL hydrochloride orally disintegrating tablets, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
8d682a51-31d0-43e6-9fab-6eb5219f5a41
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2019
Manufacturers
FDA
Hisun Pharmaceuticals USA, Inc.
DUNS: 961628505
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 Code42658-120
Application NumberANDA205269
Product Classification
M
Marketing Category
C73584
G
Generic Name
donepezil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2019
FDA Product Classification
INGREDIENTS (9)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
Donepezil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42658-119
Application NumberANDA205269
Product Classification
M
Marketing Category
C73584
G
Generic Name
Donepezil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2019
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DONEPEZIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT