LABETALOL HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]

LABETALOL HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]
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NDC 52533-034-20
Set ID f0a9df5b-45b5-4be5-aeb6-76d0c27a7799
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Cantrell Drug Company
Generic Name
Product Class beta-Adrenergic Blocker
Product Number
Application Number
  • Label

    Label

  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    LABETALOL HCL 
    labetalol hcl injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-034
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52533-034-204 mL in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/23/2012
    Labeler - Cantrell Drug Company (035545763)