FLUCELVAX QUADRIVALENT

Product NDC: 70461-319
11-digit product format: 704610319
Labeler code: 70461
Product ID: 70461-319_e3d32ead-4603-4ce6-bea5-294c7d493cbf
Type: VACCINE
Nonproprietary name: INFLUENZA A VIRUS A/IDAHO/07/2018 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED, INFLUENZA A VIRUS A/INDIANA/08/2018 (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/IOWA/06/2017 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: Seqirus, Inc.
Application: BLA125408
Marketing category: BLA
Marketing start: 2016-05-23
Marketing end: 2020-07-31
Substance: INFLUENZA A VIRUS A/IDAHO/07/2018 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED; INFLUENZA A VIRUS A/INDIANA/08/2018 (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/IOWA/06/2017 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70461-319		D	Discontinued by firm		2026-07-31
excluded package	package	70461-319	70461-319-03	D	Discontinued by firm		2026-07-31

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70461-319-03	ML - Milliliter	70461-319	8e931cf8-6211-43ed-97a2-f75cd47a9ed3	1	2019-08-06
70461-319-04	ML - Milliliter	70461-319	8d624c96-4e01-4da2-a9d1-d1f8918f9377	1	2019-08-06

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125408	Flucelvax, Flucelvax Quadrivalent	Influenza Vaccine	351(a)	Disc	2026-06-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
Z5EJE3EP8T	INFLUENZA A VIRUS A/INDIANA/08/2018 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	INFLUENZA A VIRUS A/INDIANA/08/2018 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
G4VX46P9M6	INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
CA1YT4NE3M	INFLUENZA B VIRUS B/IOWA/06/2017 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	INFLUENZA B VIRUS B/IOWA/06/2017 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)