Label: LABETALOL HCL - labetalol hydrochloride injection, solution 

  • Label RSS
  • 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 LABEL Item Code (Source) NDC:52533-034
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Anhydrous Dextrose 45 mg  in 1 mL
    Edetate Disodium 0.1 mg  in 1 mL
    Methylparaben 0.8 mg  in 1 mL
    Propylparaben 0.1 mg  in 1 mL
    Citric Acid Monohydrate  
    Sodium Hydroxide  
    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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