FLUCELVAX QUADRIVALENT- influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated) injection, suspension 
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These highlights do not include all the information needed to use FLUCELVAX ®QUADRIVALENT safely and effectively. See full prescribing information for FLUCELVAX QUADRIVALENT.

FLUCELVAX QUADRIVALENT (Influenza Vaccine)
Suspension for Intramuscular Injection
2023-2024 Formula
Initial U.S. Approval: 2016

Principal Display Panel – 0.5 mL Carton Label

For use in persons 6 months of age and older

For Intramuscular Injection Only

Ten 0.5 mL, single-dose, pre-filled syringes

Rx Only

Influenza Vaccine

FLUCELVAX®

QUADRIVALENT

2023 – 2024 Formula

Seqirus™

Principal Display Panel – 0.5 mL Carton Label

Principal Display Panel – 0.5 mL Syringe Label

Influenza Vaccine

FLUCELVAX®

QUADRIVALENT

2023 - 2024 Formula

0.5 mL dose

Rx Only

FOR IM USE ONLY

Principal Display Panel – 0.5 mL Syringe Label
FLUCELVAX QUADRIVALENT 
influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:83703-037
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: B8P3XN76W4) (INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:N8JKS3VK2A) INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
INFLUENZA A VIRUS A/DARWIN/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: PV9K2R8HRM) (INFLUENZA A VIRUS A/DARWIN/11/2021 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:C6PM4NXJ33) INFLUENZA A VIRUS A/DARWIN/11/2021 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: TUE3AGP9ME) (INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:C76JLA4DM6) INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: G4VX46P9M6) (INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:0JXM8X6ZW8) INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83703-037-0310 in 1 CARTON
1NDC:83703-037-040.5 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12540807/01/202307/31/2024
Labeler - Bamboo US BidCo LLC (119087615)
Establishment
NameAddressID/FEIBusiness Operations
Seqirus Inc.080102141manufacture, label, pack, analysis

Revised: 6/2024
Document Id: 1b182784-3fc1-4a5f-e063-6294a90a11cd
Set id: 1a525ed7-5c81-f086-e063-6294a90a7797
Version: 3
Effective Time: 20240617
 
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