FDA.reportPublic FDA data

FLUZONE QUADRIVALENT

Product NDC
49281-421
Requested package NDC
49281-421-10
11-digit product format
492810421
Labeler code
49281
Product ID
49281-421_2f62f524-abf7-4d52-bfca-c30c3d0dde4c
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (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
2021-07-02
Marketing end
2022-06-30
Substance
INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (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 packagepackage49281-42149281-421-10DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-421-10ML - Milliliter49281-421646788d5-ba50-4f03-9ed7-eb34d44223f512021-08-05
49281-421-50ML - Milliliter49281-42168b7843b-1f4c-4afa-80a1-36203d86b18d12021-08-05
49281-421-58ML - Milliliter49281-421382f45e2-da01-4231-908e-fafa46e6053f12021-08-05
49281-421-88ML - Milliliter49281-42194880a1a-1e4d-413d-8d3c-1bf5732e648b12021-08-05

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
49281-421-104928104211010 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-421-10) > .5 mL in 1 VIAL, SINGLE-DOSE (49281-421-58) 2021-07-022022-06-30NoNoCurrent