FLUARIX QUADRIVALENT

Product NDC: 58160-887
Requested package NDC: 58160-887-52
11-digit product format: 581600887
Labeler code: 58160
Product ID: 58160-887_eea6e717-9fe9-48cb-848d-2685fe8f0970
Type: VACCINE
Nonproprietary name: influenza virus vaccine
Dosage form: SUSPENSION
Route: INTRAMUSCULAR
Labeler: GlaxoSmithKline Biologicals SA
Application: BLA125127
Marketing category: BLA
Marketing start: 2021-07-02
Marketing end: 2022-06-30
Substance: INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58160-887	58160-887-52	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
58160-887-41	ML - Milliliter	58160-887	4ad7b49b-53cf-4123-a6c8-00b47a10f1a8	1	2021-08-05
58160-887-52	ML - Milliliter	58160-887	60b134cc-349c-4759-9b12-a60f64bc05f1	1	2021-08-05

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
58160-887-52	58160088752	10 SYRINGE in 1 CARTON (58160-887-52) > .5 mL in 1 SYRINGE (58160-887-41)	10 syringe	2021-07-02	2022-06-30	No	No	Current