United States· US:58160-725_2d728e3c-d550-47fb-8fa9-3ce0f244512b
FLUARIX
A medicinal product containing influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated); influenza a virus a/croatia/10136rv/2023 x-425a (h3n2) antigen (formaldehyde inactivated); influenza b virus b/austria/1359417/2021 bvr-26 antigen (formaldehyde inactivated), registered in United States by GlaxoSmithKline Biologicals SA.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Manufacturer
- GlaxoSmithKline Biologicals SA
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 1
- ndc1158160-725-52
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/f63c9406-8aa2-46d6-ad39-14860a746096 GET /v1/drugs/f63c9406-8aa2-46d6-ad39-14860a746096?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRAMUSCULAR",
"source": "ndc",
"strength": "15; 15; 15",
"substance": "INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"productndc": "58160-725",
"dosage_form": "SUSPENSION",
"dea_schedule": null,
"strength_unit": "ug/.5mL; ug/.5mL; ug/.5mL",
"application_number": "BLA125127",
"marketing_category": "BLA"
}See everything about influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated); influenza a virus a/croatia/10136rv/2023 x-425a (h3n2) antigen (formaldehyde inactivated); influenza b virus b/austria/1359417/2021 bvr-26 antigen (formaldehyde inactivated).
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.