FDA.reportPublic FDA data

Flucelvax Quadrivalent

Product NDC
70461-422
11-digit product format
704610422
Labeler code
70461
Product ID
70461-422_86fb1dd8-fc0c-4b78-95fe-80cd854a9874
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Seqirus Inc.
Application
BLA125408
Marketing category
BLA
Marketing start
2022-07-01
Marketing end
2023-07-31
Substance
INFLUENZA A VIRUS A/DARWIN/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/DELAWARE/55/2019 CVR-45 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70461-422DDiscontinued by firm2026-07-31
excluded packagepackage70461-42270461-422-10DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70461-422-10ML - Milliliter70461-422a6ff4ec7-ace3-4028-9af4-9ead7785091a12022-08-04
70461-422-11ML - Milliliter70461-42224ce75cb-13ee-48b9-9772-e0cb6ed3e12e12022-08-04

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125408Flucelvax, Flucelvax QuadrivalentInfluenza Vaccine351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70461-422-10704610422101 VIAL, MULTI-DOSE in 1 CARTON (70461-422-10) > 5 mL in 1 VIAL, MULTI-DOSE (70461-422-11) 2022-07-012023-07-31NoNoCurrent