Label: BUPRENORPHINE solution

  • NDC Code(s): 70022-010-03
  • Packager: PAYLESS COMPOUNDERS, LLC
  • Category: ANIMAL COMPOUNDED DRUG
  • DEA Schedule: CIII
  • Marketing Status: unapproved drug other

Drug Label Information

Updated October 2, 2015

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  • PRINCIPAL DISPLAY PANEL

    buprenorphine oral solution 30mL
  • INGREDIENTS AND APPEARANCE
    BUPRENORPHINE 
    buprenorphine solution
    Product Information
    Product TypeANIMAL COMPOUNDED DRUGItem Code (Source)NDC:70022-010
    Route of AdministrationORAL, TRANSMUCOSALDEA ScheduleCIII    
    Reporting Period20151002-20160402
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) BUPRENORPHINE0.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70022-010-0330 mL in 1 BOTTLE, PLASTIC; Number of Units = 30
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/02/2015
    Labeler - PAYLESS COMPOUNDERS, LLC (031728341)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAYLESS COMPOUNDERS, LLC604160239outsourcing animal drug compounding
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