FDA.reportPublic FDA data

FLUCELVAX QUADRIVALENT

Product NDC
70461-421
11-digit product format
704610421
Labeler code
70461
Product ID
70461-421_e3fac12e-d9ec-4e58-b404-ed2abc40102f
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019 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
2020-07-02
Marketing end
2022-07-31
Substance
INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 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 productproduct70461-421DDiscontinued by firm2026-08-03
excluded packagepackage70461-42170461-421-10DDiscontinued by firm2026-08-03

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70461-421-10ML - Milliliter70461-4219f7e4eb8-dc3d-4984-9f6b-45b2bbd9d38412021-08-05
70461-421-11ML - Milliliter70461-4217c632969-97d5-4df8-a34f-8353564c323812021-08-05

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
70461-421-10704610421101 VIAL, MULTI-DOSE in 1 CARTON (70461-421-10) > 5 mL in 1 VIAL, MULTI-DOSE (70461-421-11) 2020-07-022022-07-31NoNoCurrent