Label: BUPRENORPHINE injection, solution
BUPRENORPHINE solution

  • NDC Code(s): 70022-001-10, 70022-004-10, 70022-010-03, 70022-010-10
  • Packager: PAYLESS COMPOUNDERS, LLC
  • Category: ANIMAL COMPOUNDED DRUG

Drug Label Information

Updated May 14, 2024

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  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    Buprenorphine MDV 0.3mg/mL
  • PRINCIPAL DISPLAY PANEL

    buprenorphine inj MDV 0.6mg/mL
  • PRINCIPAL DISPLAY PANEL

    buprenorphine oral solution 30mL
  • PRINCIPAL DISPLAY PANEL

    buprenorphine oral solution 100mL
  • INGREDIENTS AND APPEARANCE
    BUPRENORPHINE 
    buprenorphine injection, solution
    Product Information
    Product TypeANIMAL COMPOUNDED DRUGItem Code (Source)NDC:70022-001
    Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUSDEA ScheduleCIII    
    Reporting Period20240701-20241231
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) (Source NDC: 38779-0888)BUPRENORPHINE0.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    MANNITOL (UNII: 3OWL53L36A)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70022-001-1010 mL in 1 VIAL, MULTI-DOSE; Number of Units = 10
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    BUPRENORPHINE 
    buprenorphine solution
    Product Information
    Product TypeANIMAL COMPOUNDED DRUGItem Code (Source)NDC:70022-004
    Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUSDEA ScheduleCIII    
    Reporting Period20240701-20241231
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) (Source NDC: 38779-0888)BUPRENORPHINE0.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MANNITOL (UNII: 3OWL53L36A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70022-004-1010 mL in 1 VIAL, MULTI-DOSE; Number of Units = 10
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    BUPRENORPHINE 
    buprenorphine solution
    Product Information
    Product TypeANIMAL COMPOUNDED DRUGItem Code (Source)NDC:70022-010
    Route of AdministrationORAL, TRANSMUCOSALDEA ScheduleCIII    
    Reporting Period20240701-20241231
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) (Source NDC: 38779-0888)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
    2NDC:70022-010-10100 mL in 1 BOTTLE, PLASTIC; Number of Units = 100
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Labeler - PAYLESS COMPOUNDERS, LLC (031728341)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAYLESS COMPOUNDERS, LLC604160239outsourcing animal drug compounding