FLUCELVAX QUADRIVALENT

Product NDC: 70461-321
Requested package NDC: 70461-321-03
11-digit product format: 704610321
Labeler code: 70461
Product ID: 70461-321_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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70461-321	70461-321-03	D	Discontinued by firm		2026-08-03

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70461-321-03	ML - Milliliter	70461-321	1ce4a441-cd01-437a-b3d4-0afd16c202fc	1	2021-08-05
70461-321-04	ML - Milliliter	70461-321	8dcad54d-70e0-4fcd-93a2-9e7984922b41	1	2021-08-05

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
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)

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70461-321-03	70461032103	10 SYRINGE, GLASS in 1 CARTON (70461-321-03) > .5 mL in 1 SYRINGE, GLASS (70461-321-04)	2020-07-02	2022-07-31	No	No	Current