Flublok Quadrivalent Northern Hemisphere

Product NDC
49281-720
11-digit product format
492810720
Labeler code
49281
Product ID
49281-720_4c51a757-868c-4cfe-a9a3-f138735badc5
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/HAWAII/70/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/MINNESOTA/41/2019 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/WASHINGTON/02/2019 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
2020-07-02
Marketing end
2021-06-30
Substance
INFLUENZA A VIRUS A/HAWAII/70/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/MINNESOTA/41/2019 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/WASHINGTON/02/2019 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-720-10ML - Milliliter49281-72014dae1f0-dd33-4f5d-bd6b-1cd21677084212020-08-06
49281-720-88ML - Milliliter49281-720241fc7d9-d0d7-4488-8765-eeee2abbf61912020-08-06

Purple Book Biologic Products#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-720-104928107201010 SYRINGE in 1 CARTON (49281-720-10) > .5 mL in 1 SYRINGE (49281-720-88) 10 syringe2020-07-022021-06-30NoNoCurrent