FLUARIX QUADRIVALENT

Product NDC: 58160-896
11-digit product format: 581600896
Labeler code: 58160
Product ID: 58160-896_242326af-efc3-45bd-9b15-c079dfac491c
Type: VACCINE
Nonproprietary name: influenza virus vaccine
Dosage form: SUSPENSION
Route: INTRAMUSCULAR
Labeler: GlaxoSmithKline Biologicals SA
Application: BLA125127
Marketing category: BLA
Marketing start: 2019-07-02
Marketing end: 2020-06-30
Substance: INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE 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	58160-896		D	Discontinued by firm		2026-07-31
excluded package	package	58160-896	58160-896-52	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
58160-896-41	ML - Milliliter	58160-896	475f6999-cdef-4acc-b6de-7b70f16f83e0	1	2019-08-06
58160-896-52	ML - Milliliter	58160-896	08af0a7a-bbb2-49e0-b116-f06bde70d6e3	1	2019-08-06

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125127	Fluarix, Fluarix Quadrivalent	Influenza Vaccine	351(a)	Rx	2026-06-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
XW4JB03TI5	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)
3NZW5ND3D6	INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)	INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)
M691J375MM	INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)	INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)
B93BQX9789	INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)	INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)