FDA.reportPublic FDA data

FLUBLOK TRIVALENT NORTHERN HEMISPHERE

Product NDC
49281-725
11-digit product format
492810725
Labeler code
49281
Product ID
49281-725_07174da3-a257-4ad4-8ad4-0e90bbb6f9e8
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/WEST VIRGINIA/30/2022 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/District of Columbia/27/2023 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Sanofi Pasteur Inc.
Application
BLA125285
Marketing category
BLA
Marketing start
2025-07-01
Marketing end
2026-06-30
Substance
INFLUENZA A VIRUS A/DISTRICT OF COLUMBIA/27/2023 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/WEST VIRGINIA/30/2022 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN
Active strength
45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL
NDC exclude flag
No
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49281-725DDiscontinued by firm2026-08-03
excluded packagepackage49281-72549281-725-10DDiscontinued by firm2026-08-03

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-725-10FLUBLOK TRIVALENT NORTHERN HEMISPHERE10 in 1 CARTONINJECTION108
49281-725-88FLUBLOK TRIVALENT NORTHERN HEMISPHERE0.5 mL in 1 SYRINGEINJECTION0.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-725-10ML - Milliliter49281-725c22af107-9bff-43c1-8c59-c210210663a212025-08-11
49281-725-88ML - Milliliter49281-72585d9a451-e626-4b7b-9b87-c2028418eebd12025-08-11

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
2719311Flublok 2025-2026 vaccine 0.5 ML Prefilled SyringePSN0c3cd915-babe-49c0-8aac-bf0247a17f3e8
2719304influenza virus vaccine 2025-2026 (trivalent - District of Columbia/West Virginia/Austria) 0.5 ML Prefilled SyringePSN0c3cd915-babe-49c0-8aac-bf0247a17f3e8
27193110.5 ML influenza A virus A/District of Columbia/27/2023 (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 Prefilled Syringe [Flublok 2025-2026]SBD0c3cd915-babe-49c0-8aac-bf0247a17f3e8
27193040.5 ML influenza A virus A/District of Columbia/27/2023 (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 Prefilled SyringeSCD0c3cd915-babe-49c0-8aac-bf0247a17f3e8
2719311Flublok 2025-2026 vaccine 0.5 ML Prefilled SyringeSY0c3cd915-babe-49c0-8aac-bf0247a17f3e8
2719304influenza virus vaccine 2025-2026 (trivalent - District of Columbia/West Virginia/Austria) 0.5 ML Prefilled SyringeSY0c3cd915-babe-49c0-8aac-bf0247a17f3e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-725-104928107251010 SYRINGE in 1 CARTON (49281-725-10) / .5 mL in 1 SYRINGE (49281-725-88) 10 syringe2025-07-012026-06-30NoNoHistorical
49281-725-88492810725880.5 mL in 1 SYRINGE0.5 mlHistorical