Label: FLUVIRIN (a/singapore/gp1908/2015 ivr-180 (an a/michigan/45/2015 (h1n1)pdm09-like virus, a/hong kong/4801/2014, nymc x-263b (h3n2) (an a/hong kong/4801/2014-like virus), and b/brisbane/60/2008, wild type- a b/brisbane/60/2008-like virus injection, suspension

  • Category: LICENSED VACCINE BULK INTERMEDIATE LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated January 4, 2018

If you are a consumer or patient please visit this version.

View All Sections
  • PRINCIPAL DISPLAY PANEL

    bulk label

  • INGREDIENTS AND APPEARANCE
    FLUVIRIN 
    a/singapore/gp1908/2015 ivr-180 (an a/michigan/45/2015 (h1n1)pdm09-like virus, a/hong kong/4801/2014, nymc x-263b (h3n2) (an a/hong kong/4801/2014-like virus), and b/brisbane/60/2008, wild type (a b/brisbane/60/2008-like virus) injection, suspension
    Product Information
    Product TypeLICENSED VACCINE BULK INTERMEDIATEItem Code (Source)NDC:43835-0019
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 3872LLC68G) (INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:3872LLC68G) INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
    INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 3S1ZBQ2B9I) (INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:3S1ZBQ2B9I) INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
    INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: H41XP0E6G8) (INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:W3D48FDO26) INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    THIMEROSAL (UNII: 2225PI3MOV)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43835-0019-140 in 1 BOX
    110 in 1 CARTON
    10.5 mL in 1 SYRINGE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10383709/15/2013
    Labeler - Catalent Belgium SA (370696762)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalent Belgium SA370696762manufacture(43835-0019) , analysis(43835-0019)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!