FDA.reportPublic FDA data

FLUZONE QUADRIVALENT NORTHERN HEMISPHERE

Product NDC
49281-422
Requested package NDC
49281-422-10
11-digit product format
492810422
Labeler code
49281
Product ID
49281-422_dbab8882-0dd3-4e84-a33d-3d57cbdc8163
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Sanofi Pasteur Inc.
Application
BLA103914
Marketing category
BLA
Marketing start
2022-07-01
Marketing end
2023-06-30
Substance
INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 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 packagepackage49281-42249281-422-10DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-422-10ML - Milliliter49281-422450d7ab8-917b-4d5f-92d9-63196724e8fc12022-08-04
49281-422-50ML - Milliliter49281-4220871f41c-0ea1-4d73-9864-83aad19ee84312022-08-04
49281-422-58ML - Milliliter49281-4229fb30673-2401-4289-b605-406b500dd2bd12022-08-04
49281-422-88ML - Milliliter49281-4224954230d-82c0-417f-bf27-b1f25b1ecfa512022-08-04

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
49281-422-104928104221010 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-422-10) > .5 mL in 1 VIAL, SINGLE-DOSE (49281-422-58) 2022-07-012023-06-30NoNoCurrent