FDA.reportPublic FDA data

FLUCELVAX QUADRIVALENT

Product NDC
70461-320
Requested package NDC
70461-320-03
11-digit product format
704610320
Labeler code
70461
Product ID
70461-320_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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70461-32070461-320-03DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70461-320-03ML - Milliliter70461-32095d99bbd-9ee1-4341-b9d3-f55296899d2f12020-08-06
70461-320-04ML - Milliliter70461-320f22f6d63-bfc6-4dd0-b1f1-b1e942f6cbd512020-08-06

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
70461-320-037046103200310 SYRINGE, GLASS in 1 CARTON (70461-320-03) > .5 mL in 1 SYRINGE, GLASS (70461-320-04) 2020-07-022021-07-31NoNoCurrent