Label: INSTANYL- fentanyl nasal spray spray

  • NDC Code(s): 49396-0512-1
  • Packager: Renaissance Lakewood LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: Export only

Drug Label Information

Updated March 3, 2023

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  • Instanyl single dose nasal spray carton

    instanyl single dose nasal spray carton

  • INGREDIENTS AND APPEARANCE
    INSTANYL 
    fentanyl nasal spray spray
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49396-0512
    Route of AdministrationNASALDEA ScheduleCII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FENTANYL CITRATE (UNII: MUN5LYG46H) (FENTANYL - UNII:UF599785JZ) FENTANYL2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49396-0512-150 in 1 CARTON06/29/2011
    10.125 mL in 1 VIAL; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only06/29/2011
    Labeler - Renaissance Lakewood LLC (077744035)
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