Label: DONEPEZIL HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 65841-749-01, 65841-749-05, 65841-749-06, 65841-749-10, view more
    65841-749-16, 65841-749-30, 65841-750-01, 65841-750-05, 65841-750-06, 65841-750-10, 65841-750-16, 65841-750-30
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 5, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-749-01 in bottle of 100 tablets

    Donepezil Hydrochloride Tablets USP, 5 mg

    Rx only

    100 tablets

    Donepezil HCl Tablets, USP

    NDC 65841-750-01 in bottle of 100 tablets

    Donepezil Hydrochloride Tablets USP, 10 mg

    Rx only

    100 tablets

    Donepezil HCl Tablets, USP
  • INGREDIENTS AND APPEARANCE
    DONEPEZIL HYDROCHLORIDE 
    donepezil hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-749
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P) DONEPEZIL HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZF9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-749-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
    2NDC:65841-749-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
    3NDC:65841-749-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
    4NDC:65841-749-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
    5NDC:65841-749-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
    6NDC:65841-749-3010 in 1 CARTON05/25/2011
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09010005/25/2011
    DONEPEZIL HYDROCHLORIDE 
    donepezil hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-750
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P) DONEPEZIL HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code ZF10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-750-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
    2NDC:65841-750-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
    3NDC:65841-750-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
    4NDC:65841-750-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
    5NDC:65841-750-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
    6NDC:65841-750-3010 in 1 CARTON05/25/2011
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09010005/25/2011
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-749, 65841-750) , MANUFACTURE(65841-749, 65841-750)
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