Label: LABETALOL HCL - labetalol hydrochloride injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 05/14

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  • Label
  • INGREDIENTS AND APPEARANCE
    LABETALOL HCL 
    labetalol hcl injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-034
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Anhydrous Dextrose (UNII: 5SL0G7R0OK) 45 mg  in 1 mL
    Edetate Disodium (UNII: 7FLD91C86K) 0.1 mg  in 1 mL
    Methylparaben (UNII: A2I8C7HI9T) 0.8 mg  in 1 mL
    Propylparaben (UNII: Z8IX2SC1OH) 0.1 mg  in 1 mL
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52533-034-20 4 mL in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/23/2012
    Labeler - Cantrell Drug Company (035545763)
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