FLUARIX QUADRIVALENT

Product NDC: 58160-890
Requested package NDC: 58160-890-52
11-digit product format: 581600890
Labeler code: 58160
Product ID: 58160-890_c53d4a8d-2af8-4c04-ab36-9206bc03dce4
Type: VACCINE
Nonproprietary name: influenza virus vaccine
Dosage form: SUSPENSION
Route: INTRAMUSCULAR
Labeler: GlaxoSmithKline Biologicals SA
Application: BLA125127
Marketing category: BLA
Marketing start: 2022-07-01
Marketing end: 0000-00-00
Substance: INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 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: 2023-12-31
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	58160-890	58160-890-52	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
58160-890-41	ML - Milliliter	58160-890	46d95f20-bd38-452c-86d5-e64cc315bc47	1	2022-08-04
58160-890-52	ML - Milliliter	58160-890	0ca396ab-52a5-4f2d-936a-837a2fea4235	1	2022-08-04

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
B93BQX9789	INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)	INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58160-890-52	58160089052	10 SYRINGE in 1 CARTON (58160-890-52) > .5 mL in 1 SYRINGE (58160-890-41)	10 syringe	2022-07-01	0000-00-00	No	No	Current