NDC 33332-015

AFLURIA

Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223 (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (propiolactone Inactivated)

AFLURIA is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Biocsl Pty Ltd.. The primary component is Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated); Influenza A Virus A/south Australia/55/2014 Ivr-175 (h3n2) Antigen (propiolactone Inactivated); Influenza B Virus B/phuket/3073/2013 Antigen (propiolactone Inactivated).

Product ID33332-015_91776d76-04ff-438a-84a8-08d54e161ae0
NDC33332-015
Product TypeVaccine
Proprietary NameAFLURIA
Generic NameInfluenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223 (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (propiolactone Inactivated)
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2011-07-15
Marketing CategoryBLA / BLA
Application NumberBLA125254
Labeler NamebioCSL Pty Ltd.
Substance NameINFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (PROPIOLACTONE INACTIVATED)
Active Ingredient Strength15 ug/.5mL; ug/.5mL; ug/.5mL
Pharm ClassesInactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Influenza Vaccines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 33332-015-01

10 SYRINGE, GLASS in 1 CARTON (33332-015-01) > .5 mL in 1 SYRINGE, GLASS (33332-015-02)
Marketing Start Date2011-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33332-015-01 [33332001501]

AFLURIA INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125254
Product TypeVACCINE
Billing UnitML
Marketing Start Date2011-07-15
Marketing End Date2016-12-31

NDC 33332-015-02 [33332001502]

AFLURIA INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125254
Product TypeVACCINE
Billing UnitML
Marketing Start Date2011-07-15
Marketing End Date2016-12-31

Drug Details

Active Ingredients

IngredientStrength
INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED)15 ug/.5mL

Pharmacological Class

  • Inactivated Influenza A Virus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Vaccines
  • Inactivated [CS]
  • Influenza Vaccines [CS]

NDC Crossover Matching brand name "AFLURIA" or generic name "Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223 (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (propiolactone Inactivated)"

NDCBrand NameGeneric Name
33332-015AFLURIAINFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED)
33332-018AFLURIAINFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED)
33332-115AFLURIAINFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED)
33332-118AFLURIAINFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED)

Trademark Results [AFLURIA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFLURIA
AFLURIA
79004750 3057916 Live/Registered
CSL Limited
2004-07-13
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