FLUCELVAX (Influenza Vaccine) These highlights do not include all the information needed to use FLUCELVAX ®safely and effectively. See full prescribing information for FLUCELVAX. Injectable Suspension, for Intramuscular Use 2024-2025 Formula Initial U.S. Approval: 2012

Flucelvax by

Drug Labeling and Warnings

Flucelvax by is a Other medication manufactured, distributed, or labeled by Bamboo US BidCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLUCELVAX- influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/sydney/1304/2022 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated) injection, suspension 
Bamboo US BidCo LLC

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FLUCELVAX (Influenza Vaccine)

These highlights do not include all the information needed to use FLUCELVAX ®safely and effectively. See full prescribing information for FLUCELVAX.

Injectable Suspension, for Intramuscular Use
2024-2025 Formula
Initial U.S. Approval: 2012

Principal Display Panel – 0.5 mL Carton Label

For use in persons 6 months of age and older

For Intramuscular Use

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

Rx Only

Influenza Vaccine
FLUCELVAX®

2024 - 2025 FORMULA

Seqirus

Principal Display Panel – 0.5 mL Carton Label

Principal Display Panel – 0.5 mL Syringe Label

Influenza Vaccine
FLUCELVAX®

2024 - 2025 FORMULA

0.5 mL dose

Rx Only

FOR IM USE

For 6 months of age
and older

Principal Display Panel – 0.5 mL Syringe Label

FLUCELVAX 
influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/sydney/1304/2022 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC: 83703-062
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/SYDNEY/1304/2022 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 2DVY566JY6) (INFLUENZA A VIRUS A/SYDNEY/1304/2022 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:5CH2Y25VXX) INFLUENZA A VIRUS A/SYDNEY/1304/2022 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
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: 83703-062-0310 in 1 CARTON
1NDC: 83703-062-040.5 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
BLABLA12540807/01/2024
Labeler - Bamboo US BidCo LLC (119087615)

Revised: 6/2025
 

Trademark Results [Flucelvax]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLUCELVAX
FLUCELVAX
85074013 3890355 Live/Registered
SEQIRUS UK LIMITED
2010-06-29

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