Label: DONEPEZIL HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 70771-1320-0, 70771-1320-1, 70771-1320-2, 70771-1320-3, view more
    70771-1320-4, 70771-1320-5, 70771-1320-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 21, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1320-1 in bottle of 100 tablets

    Donepezil Hydrochloride Tablets, 23 mg

    Rx only

    100 tablets

    donepezilhacltabs-image05
  • INGREDIENTS AND APPEARANCE
    DONEPEZIL HYDROCHLORIDE 
    donepezil hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P) DONEPEZIL HYDROCHLORIDE23 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorRED (red-brown) Scoreno score
    ShapeROUND (round) Size8mm
    FlavorImprint Code 521
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1320-330 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
    2NDC:70771-1320-990 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
    3NDC:70771-1320-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
    4NDC:70771-1320-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
    5NDC:70771-1320-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
    6NDC:70771-1320-410 in 1 CARTON03/07/2018
    6NDC:70771-1320-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20316203/07/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1320) , MANUFACTURE(70771-1320)