FDA.reportPublic FDA data

FLUZONE QUADRIVALENT

Product NDC
49281-420
Requested package NDC
49281-420-50
11-digit product format
492810420
Labeler code
49281
Product ID
49281-420_f5da9c8e-5601-41eb-acdc-65ddc41a6599
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Sanofi Pasteur Inc.
Application
BLA103914
Marketing category
BLA
Marketing start
2020-07-02
Marketing end
2021-06-30
Substance
INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
15 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49281-42049281-420-50DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-420-10ML - Milliliter49281-4208089ba3f-98dc-4533-9d7e-963c07b753ff12020-08-06
49281-420-50ML - Milliliter49281-4208df14882-0473-4530-aa62-bab38d7636e412020-08-06
49281-420-58ML - Milliliter49281-420578bb630-be8b-4378-8306-185f53a5ad2112020-08-06
49281-420-88ML - Milliliter49281-42021afbca4-d555-4b2f-bb70-2acd89376c5112020-08-06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103914Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone QuadrivalentInfluenza Virus Vaccine351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49281-420-504928104205010 SYRINGE, GLASS in 1 PACKAGE (49281-420-50) > .5 mL in 1 SYRINGE, GLASS (49281-420-88) 2020-07-022021-06-30NoNoCurrent