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FDA Approval

Donepezil Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
February 14, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Donepezil(10 mg in 1 1)

Products2

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 Code
42658-120
Application Number
ANDA205269
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 14, 2019
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PEPPERMINTInactive
Code: V95R5KMY2BClass: IACT
DonepezilActive
Code: 3O2T2PJ89DClass: ACTIBQuantity: 10 mg in 1 1

Donepezil Hydrochloride

Product Details

NDC Product Code
42658-119
Application Number
ANDA205269
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 14, 2019
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DonepezilActive
Code: 3O2T2PJ89DClass: ACTIBQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
PEPPERMINTInactive
Code: V95R5KMY2BClass: IACT
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