Label: MKH DOSE PACK- midazolam - ketamine hcl - hydroxyzine hcl 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 March 5, 2019

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  • STORAGE AND HANDLING

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

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  • Package Label
  • INGREDIENTS AND APPEARANCE
    MKH DOSE PACK 
    midazolam - ketamine hcl - hydroxyzine hcl troche
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71384-420
    Route of Administration SUBLINGUAL DEA Schedule CIII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    KETAMINE HYDROCHLORIDE (UNII: O18YUO0I83) (KETAMINE - UNII:690G0D6V8H) KETAMINE 25 mg
    MIDAZOLAM (UNII: R60L0SM5BC) (MIDAZOLAM - UNII:R60L0SM5BC) MIDAZOLAM 3 mg
    HYDROXYZINE HYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG) HYDROXYZINE HYDROCHLORIDE 10 mg
    Product Characteristics
    Color white (Off White) Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71384-420-03 3 in 1 DOSE PACK; Type 0: Not a Combination Product 03/04/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/04/2019
    Labeler - Imprimis NJOF, LLC (080431967)
    Registrant - Imprimis NJOF, LLC (080432967)
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