FDA.reportPublic FDA data

FLUCELVAX (Influenza Vaccine)

Manufacturer
Bamboo US BidCo LLC
Effective date
2026-06-17
Label type
VACCINE LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-04 03:34:04

Label at a glance#

ProductFlucelvax
Active ingredientINFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INAC..., INFLUENZA A VIRUS A/VICTORIA/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE IN..., INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 ®

2026 - 2027 FORMULA

Seqirus™

55

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – 0.5 mL Syringe Label

Influenza Vaccine
FLUCELVAX ®

2026 - 2027 Formula

0.5 mL dose

Rx Only

FOR IM USE

For 6 months of age
and older

66

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Limited(01)00370461656048GTIN-14: 00370461656048
GTIN-12: 370461656048
UPC-A: 370461656048
EAN-13: 0370461656048
GTIN storage (14 digits): 00370461656048		image 1.jpg
Data codeData Matrix6564image 2.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83703-08883703-088-04, 83703-088-03

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125408Flucelvax, Flucelvax QuadrivalentInfluenza Vaccine351(a)Disc2026-09-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM CHLORIDE451W47IQ8XIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TIACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT
WATER059QF0KO0RIACT
INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)B8P3XN76W4ACTIM
INFLUENZA A VIRUS A/VICTORIA/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)4HH5SUR63TACTIM
INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)TUE3AGP9MEACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 10 · 196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDECardinal Health 107, LLCea55ded1-e076-43de-ad3c-c75e7d0a4ebc2026-08-24Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDECoupler LLC598f61d7-a665-5d02-e063-6394a90a89052026-08-21Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEPreferred Pharmaceuticals Inc.3f19ed0e-6c73-482c-94d6-d3205318fd6f2026-08-17Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals LLCf9965f73-e189-423f-bd10-c4a0ed12b4852026-08-01Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEREMEDYREPACK INC.16c775e4-0dd8-4e9f-b2bf-dd2b639374cf2026-07-31Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEREMEDYREPACK INC.7ec22e8e-6643-44fe-804d-ca0b0b2666632026-07-31Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLC02707146-331f-4511-a187-0152fc8bca852026-07-24Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticals6c080e51-4eb7-4e96-b29f-eb1cce3813042026-07-14Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEATLANTIC BIOLOGICALS CORP.104ccc91-2aaf-4bb7-bb64-77c29413f60e2026-07-10Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEHospira, Inc.559a0a8c-a8fe-40a5-b196-21f9308780ab2026-07-01Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions30527e49-6648-44f3-97b2-9c51783ac0032026-07-01Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals NY LLC590dd25c-c4cb-489a-a09b-eccbf1d37c1f2026-07-01Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDESt. Mary's Medical Park Pharmacy549c9d28-bf8b-2dc2-e063-6294a90abe7b2026-06-19Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEREMEDYREPACK INC.f75713cf-6902-4160-94cb-335a1ecdbbbe2026-06-12Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLC548953ac-31c5-a181-e063-6294a90a3b772026-06-12Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDERedpharm Drug5261dfe5-d62b-d618-e063-6294a90a96e72026-05-22Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLCd2e84d34-e042-477f-9944-3fcb953012172026-05-20Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
potassium chloridePOTASSIUM CHLORIDENorthstar Rx LLCb19a3fbf-cdbb-4f86-ac61-5dfb07e0a51a2026-05-18Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack9088ca44-5585-4551-8e2c-168f306520d42026-03-30Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE
Potassium ChloridePOTASSIUM CHLORIDEAjenat Pharmaceuticals LLCab066a84-5455-419e-a1da-354a3f15a73d2026-03-23Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.