Label: MKO MELT- midazolaam - ketamine hcl - ondansetron troche

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: unapproved drug other

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 December 1, 2018

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  • STORAGE AND HANDLING

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

  • Product Label

    Product LabelProduct Label

  • INGREDIENTS AND APPEARANCE
    MKO MELT 
    midazolaam - ketamine hcl - ondansetron troche
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-630
    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 (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS) ONDANSETRON2 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71384-630-2121 in 1 BLISTER PACK; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2018
    Labeler - Imprimis NJOF, LLC (080431967)
    Registrant - Imprimis NJOF, LLC (080431967)