FDA.reportPublic FDA data

Flucelvax

Product NDC
70461-656
11-digit product format
704610656
Labeler code
70461
Product ID
70461-656_507ef735-5913-4f01-831b-c53285db8f64
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/Tasmania/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Tasmania/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Arizona/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Application
BLA125408
Marketing category
BLA
Marketing start
2026-07-01
Marketing end
2027-07-31
Substance
INFLUENZA A VIRUS A/TASMANIA/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS - B/ARIZONA/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
Active strength
15 ug/.5mL
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Flucelvax

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLUENZA A VIRUS A/TASMANIA/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug/.5mL
INFLUENZA A VIRUS A/TASMANIA/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug/.5mL
INFLUENZA B VIRUS - B/ARIZONA/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125408Flucelvax, Flucelvax QuadrivalentInfluenza Vaccine351(a)Disc2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2718382FLUCELVAX 2025-2026 vaccine 0.5 ML Prefilled SyringePSN3513dfb0-4d62-4ad1-bb15-75c7555896ff12
2718374FLUCELVAX 2025-2026 vaccine Injectable SuspensionPSN3513dfb0-4d62-4ad1-bb15-75c7555896ff12
2718378influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) 0.5 ML Prefilled SyringePSN3513dfb0-4d62-4ad1-bb15-75c7555896ff12
2718368influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) Injectable SuspensionPSN3513dfb0-4d62-4ad1-bb15-75c7555896ff12
27183820.5 ML influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Prefilled Syringe [Flucelvax 2025-2026]SBD3513dfb0-4d62-4ad1-bb15-75c7555896ff12
2718374influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension [Flucelvax 2025-2026]SBD3513dfb0-4d62-4ad1-bb15-75c7555896ff12
27183780.5 ML influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Prefilled SyringeSCD3513dfb0-4d62-4ad1-bb15-75c7555896ff12
2718368influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable SuspensionSCD3513dfb0-4d62-4ad1-bb15-75c7555896ff12
2718382Flucelvax 2025-2026 vaccine 0.5 ML Prefilled SyringeSY3513dfb0-4d62-4ad1-bb15-75c7555896ff12
2718374Flucelvax 2025-2026 vaccine Injectable SuspensionSY3513dfb0-4d62-4ad1-bb15-75c7555896ff12
2718378influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) 0.5 ML Prefilled SyringeSY3513dfb0-4d62-4ad1-bb15-75c7555896ff12
2718368influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) Injectable SuspensionSY3513dfb0-4d62-4ad1-bb15-75c7555896ff12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleStatus
70461-656-037046106560310 SYRINGE, GLASS in 1 CARTON (70461-656-03) / .5 mL in 1 SYRINGE, GLASS (70461-656-04)2026-07-012027-07-310Historical