Label: DONEPEZIL HYDROCHLORIDE tablet, orally disintegrating

  • NDC Code(s): 65841-721-01, 65841-721-05, 65841-721-06, 65841-721-10, view more
    65841-721-16, 65841-721-30, 65841-722-01, 65841-722-05, 65841-722-06, 65841-722-10, 65841-722-16, 65841-722-30
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 13, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-721-06 in bottle of 30 tablets

    Donepezil Hydrochloride Orally Disintegrating Tablets USP, 5 mg

    Rx only

    30 tablets

    Donepezil Hydrochloride Orally Disintegrating Tablets, 5 mg

    NDC 65841-722-06 in bottle of 30 tablets

    Donepezil Hydrochloride Orally Disintegrating Tablets USP, 10 mg

    Rx only

    30 tablets

    Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg
  • INGREDIENTS AND APPEARANCE
    DONEPEZIL HYDROCHLORIDE 
    donepezil hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-721
    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
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorPEPPERMINT (flavor firmenich powder peppermint) , STRAWBERRY (flavor strawberry) Imprint Code ZF;14
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-721-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
    2NDC:65841-721-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
    3NDC:65841-721-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
    4NDC:65841-721-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
    5NDC:65841-721-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
    6NDC:65841-721-3010 in 1 CARTON05/11/2011
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09017505/11/2011
    DONEPEZIL HYDROCHLORIDE 
    donepezil hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-722
    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
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorPEPPERMINT (flavor firmenich powder peppermint) , STRAWBERRY (flavor strawberry) Imprint Code ZF;15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-722-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
    2NDC:65841-722-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
    3NDC:65841-722-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
    4NDC:65841-722-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
    5NDC:65841-722-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2011
    6NDC:65841-722-3010 in 1 CARTON05/11/2011
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09017505/11/2011
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-721, 65841-722) , MANUFACTURE(65841-721, 65841-722)
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