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 
Catalent Belgium SA

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Fluvirin

bulk 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
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
BLABLA10383709/15/201312/31/2023
Labeler - Catalent Belgium SA (370696762)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Belgium SA370696762manufacture(43835-0019) , analysis(43835-0019)

Revised: 1/2025
Document Id: 5d3a6f7e-798a-4980-a2cf-19fa3bffa410
Set id: d3b6dc88-d588-4cf4-97f2-3aa75b9e3e8b
Version: 2
Effective Time: 20250108
 
Catalent Belgium SA