Label: MKH DOSE PACK- midazolam - ketamine hcl - hydroxyzine hcl troche

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated March 5, 2019

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  • STORAGE AND HANDLING

    Store at 20° to 25° C (68° to 77° F)

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    MKH DOSE PACK 
    midazolam - ketamine hcl - hydroxyzine hcl troche
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-420
    Route of AdministrationSUBLINGUALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETAMINE HYDROCHLORIDE (UNII: O18YUO0I83) (KETAMINE - UNII:690G0D6V8H) KETAMINE25 mg
    MIDAZOLAM (UNII: R60L0SM5BC) (MIDAZOLAM - UNII:R60L0SM5BC) MIDAZOLAM3 mg
    HYDROXYZINE HYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG) HYDROXYZINE HYDROCHLORIDE10 mg
    Product Characteristics
    Colorwhite (Off White) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71384-420-033 in 1 DOSE PACK; Type 0: Not a Combination Product03/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/04/2019
    Labeler - Imprimis NJOF, LLC (080431967)
    Registrant - Imprimis NJOF, LLC (080432967)
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