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

FLUVIRIN by

Drug Labeling and Warnings

FLUVIRIN by is a Other medication manufactured, distributed, or labeled by Catalent Belgium SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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 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)