Label: POSIMIR- bupivacaine injection

  • NDC Code(s): 49396-6601-0
  • Packager: Renaissance Lakewood, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 13, 2022

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  • BOXED WARNING (What is this?)

    Product Label

    Product Image - Boxed Warning

  • PRINCIPAL DISPLAY PANEL

    Product Vial

    Product Vial Product Carton

    Product Image - Posimir

  • INGREDIENTS AND APPEARANCE
    POSIMIR 
    bupivacaine injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49396-6601
    Route of AdministrationINFILTRATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUPIVACAINE (UNII: Y8335394RO) (BUPIVACAINE - UNII:Y8335394RO) BUPIVACAINE660 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SUCROSE ACETATE ISOBUTYRATE (UNII: H5KI1C3YTV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49396-6601-010 in 1 CARTON05/31/2022
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20480305/31/2022
    Labeler - Renaissance Lakewood, LLC (077744035)
    Registrant - Renaissance Lakewood, LLC (077744035)
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