FDA.reportPublic FDA data

FLUCELVAX QUADRIVALENT

Product NDC
70461-420
11-digit product format
704610420
Labeler code
70461
Product ID
70461-420_f8b23f7c-dbf4-4217-9183-d6734ccad84d
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) 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/DARWIN/7/2019 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
2021-07-31
Substance
INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) 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/DARWIN/7/2019 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 productproduct70461-420DDiscontinued by firm2026-07-31
excluded packagepackage70461-42070461-420-10DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70461-420-10ML - Milliliter70461-420b269ca97-0763-45fe-805f-30f735a6298d12020-08-06
70461-420-11ML - Milliliter70461-420d7b7db8c-a3a2-4c37-9184-2541c36eb98312020-08-06

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
70461-420-10704610420101 VIAL, MULTI-DOSE in 1 CARTON (70461-420-10) > 5 mL in 1 VIAL, MULTI-DOSE (70461-420-11) 2020-07-022021-07-31NoNoCurrent