Label: MKO MELT DOSE PACK- midazolam - ketamine hcl - ondansetron troche

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 4, 2019

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  • Storage and Handling

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

  • Package Label

    Product Label

  • INGREDIENTS AND APPEARANCE
    MKO MELT DOSE PACK 
    midazolam - ketamine hcl - ondansetron troche
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-410
    Route of AdministrationSUBLINGUALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MIDAZOLAM (UNII: R60L0SM5BC) (MIDAZOLAM - UNII:R60L0SM5BC) MIDAZOLAM3 mg
    KETAMINE HYDROCHLORIDE (UNII: O18YUO0I83) (KETAMINE - UNII:690G0D6V8H) KETAMINE25 mg
    ONDANSETRON HYDROCHLORIDE ANHYDROUS (UNII: 2999F27MAD) (ONDANSETRON - UNII:4AF302ESOS) ONDANSETRON2 mg
    Product Characteristics
    Colorwhite (Off White) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71384-410-033 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 (080431967)