FDA.reportPublic FDA data

Flublok Quadrivalent Northern Hemisphere

Product NDC
49281-722
Requested package NDC
49281-722-10
11-digit product format
492810722
Labeler code
49281
Product ID
49281-722_5d8fddea-22f5-4bac-9326-1d11df4fbda6
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Sanofi Pasteur Inc.
Application
BLA125285
Marketing category
BLA
Marketing start
2022-07-01
Marketing end
2023-07-01
Substance
INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN
Active strength
45 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49281-72249281-722-10DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49281-72249281-722-10IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49281-72249281-722-10IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49281-722-102025-07-29C16284748780-13b156c62-31e7-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use Flublok ® Quadrivalent safely and effectively. See full prescribing information for Flublok Quadrivalent. Flublok Quadrivalent (Influenza Vaccine), Sterile Solution for Intramuscular Injection 2023-2024 Formula Initial U.S. Approval: 2013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-722-10Flublok Quadrivalent Northern Hemisphere10 in 1 CARTONINJECTION1017
49281-722-88Flublok Quadrivalent Northern Hemisphere0.5 mL in 1 SYRINGEINJECTION0.517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-722-10ML - Milliliter49281-722c01de813-e7aa-48f2-81d9-90995ec0d21112022-08-04
49281-722-88ML - Milliliter49281-7225660182e-ab6a-4b02-a330-878f3cc4a09412022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-722FLUBLOK QUADRIVALENT NORTHERN HEMISPHERE (INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN, AND INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN) INJECTION FLUBLOK QUADRIVALENT NORTHERN HEMISPHERE (INFLUENZA A VIRUS A/WEST VIRGINIA/30/2022 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN, AND INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN) INJECTION [SANOFI PASTEUR INC.]17Legacy NDC, 2 package rows20230714_67de8652-2e5a-4d18-aee9-d9b789ccfe46.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125285FlublokInfluenza Vaccine351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2605570FLUBLOK Quadrivalent 2022-2023 vaccine 0.5 ML Prefilled SyringePSN67de8652-2e5a-4d18-aee9-d9b789ccfe4617
2642315FLUBLOK Quadrivalent 2023-2024 vaccine 0.5 ML Prefilled SyringePSN67de8652-2e5a-4d18-aee9-d9b789ccfe4617
2605564influenza virus vaccine 2022-2023 (quadrivalent - Darwin/Wisconsin/Austria/Phuket) 0.5 ML Prefilled SyringePSN67de8652-2e5a-4d18-aee9-d9b789ccfe4617
2642309influenza virus vaccine 2023-2024 (quadrivalent - Darwin/6/West Virginia/Austria/Phuket) 0.5 ML Prefilled SyringePSN67de8652-2e5a-4d18-aee9-d9b789ccfe4617
26423150.5 ML influenza A virus A/Darwin/6/2021 (H3N2) antigen 0.09 MG/ML / influenza A virus A/West Virginia/30/2022 (H1N1) antigen 0.09 MG/ML / influenza B virus B/Austria/1359417/2021 antigen 0.09 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.09 MG/ML Prefilled Syringe [Flublok Quadrivalent 2023-2024]SBD67de8652-2e5a-4d18-aee9-d9b789ccfe4617
26055700.5 ML influenza A virus A/Darwin/6/2021 (H3N2) antigen 0.09 MG/ML / influenza A virus A/Wisconsin/588/2019 (H1N1) antigen 0.09 MG/ML / influenza B virus B/Austria/1359417/2021 antigen 0.09 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.09 MG/ML Prefilled Syringe [Flublok Quadrivalent 2022-2023]SBD67de8652-2e5a-4d18-aee9-d9b789ccfe4617
26423090.5 ML influenza A virus A/Darwin/6/2021 (H3N2) antigen 0.09 MG/ML / influenza A virus A/West Virginia/30/2022 (H1N1) antigen 0.09 MG/ML / influenza B virus B/Austria/1359417/2021 antigen 0.09 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.09 MG/ML Prefilled SyringeSCD67de8652-2e5a-4d18-aee9-d9b789ccfe4617
26055640.5 ML influenza A virus A/Darwin/6/2021 (H3N2) antigen 0.09 MG/ML / influenza A virus A/Wisconsin/588/2019 (H1N1) antigen 0.09 MG/ML / influenza B virus B/Austria/1359417/2021 antigen 0.09 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.09 MG/ML Prefilled SyringeSCD67de8652-2e5a-4d18-aee9-d9b789ccfe4617
2605570Flublok Quadrivalent 2022-2023 vaccine 0.5 ML Prefilled SyringeSY67de8652-2e5a-4d18-aee9-d9b789ccfe4617
2642315Flublok Quadrivalent 2023-2024 vaccine 0.5 ML Prefilled SyringeSY67de8652-2e5a-4d18-aee9-d9b789ccfe4617
2605564influenza virus vaccine 2022-2023 (quadrivalent - Darwin/Wisconsin/Austria/Phuket) 0.5 ML Prefilled SyringeSY67de8652-2e5a-4d18-aee9-d9b789ccfe4617
2642309influenza virus vaccine 2023-2024 (quadrivalent - Darwin/6/West Virginia/Austria/Phuket) 0.5 ML Prefilled SyringeSY67de8652-2e5a-4d18-aee9-d9b789ccfe4617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-722-104928107221010 SYRINGE in 1 CARTON (49281-722-10) > .5 mL in 1 SYRINGE (49281-722-88) 10 syringe2022-07-012023-07-01NoNoCurrent