Label: TIZANIDINE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 18, 2021

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  • INDICATIONS & USAGE

    Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important.

  • PRINCIPAL DISPLAY PANEL

    Tizanidine Bottle

  • INGREDIENTS AND APPEARANCE
    TIZANIDINE 
    tizanidine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80175-0169(NDC:29300-169)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TIZANIDINE HYDROCHLORIDE (UNII: B53E3NMY5C) (TIZANIDINE - UNII:6AI06C00GW) TIZANIDINE4 mg
    Product Characteristics
    ColorwhiteScore4 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code U;169
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80175-0169-330 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2013
    2NDC:80175-0169-660 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2013
    3NDC:80175-0169-990 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09128304/01/2013
    Labeler - Central Packaging (117617671)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Packaging, LLC117617671repack(80175-0169)