Label: MIDAZOLAM HCL injection, solution

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

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Drug Label Information

Updated May 2, 2014

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  • PRINCIPAL DISPLAY PANEL

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  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    MIDAZOLAM HCL 
    midazolam hcl injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-157
    Route of AdministrationINTRAVENOUSDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC) MIDAZOLAM0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X) 9 mg  in 1 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.01 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52533-157-451 mL in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/30/2013
    Labeler - Cantrell Drug Company (035545763)