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
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Contains inactivated NDC Code(s)
NDC Code(s): 43835-0019-1 - Packager: Catalent Belgium SA
- Category: LICENSED VACCINE BULK INTERMEDIATE LABEL
- DEA Schedule: None
- Marketing Status: Biologic Licensing Application
Drug Label Information
Updated January 4, 2018
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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, suspensionProduct Information Product Type LICENSED VACCINE BULK INTERMEDIATE Item Code (Source) NDC:43835-0019 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Name Strength WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) THIMEROSAL (UNII: 2225PI3MOV) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43835-0019-1 40 in 1 BOX 1 10 in 1 CARTON 1 0.5 mL in 1 SYRINGE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103837 09/15/2013 Labeler - Catalent Belgium SA (370696762) Establishment Name Address ID/FEI Business Operations Catalent Belgium SA 370696762 manufacture(43835-0019) , analysis(43835-0019)