Quick answers
- What is Baloxavir marboxil used for?
- The FDA-approved label (Xofluza, Sportpharm LLC, April 24, 2026) says: “XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Baloxavir marboxil have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Baloxavir marboxil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Baloxavir marboxil been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Baloxavir marboxil?
- 2 companies list prescription products of Baloxavir marboxil in the FDA NDC Directory, including Genentech, Inc. and Sportpharm LLC.
What Baloxavir marboxil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. …
— FDA label: Xofluza, Sportpharm LLC, effective April 24, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Granule, for suspension · Granule, for solution |
|---|---|
| Route | Oral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Xofluza |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| baloxavir marboxil 40 mg tablet, film coated | Brand: Xofluza | $161.90 per tablet |
| baloxavir marboxil 80 mg tablet, film coated | Brand: Xofluza | $161.90 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Genentech, Inc.5 products
- Sportpharm LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA210854 XOFLUZA | Genentech Inc | October 24, 2018 | 11, latest May 30, 2025 2025: Efficacy · 2025: Manufacturing (CMC) · 2024: Efficacy |
| NDA214410 XOFLUZA | Genentech Inc | November 23, 2020 | 5, latest May 30, 2025 2025: Efficacy · 2024: Efficacy · 2024: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xofluza, Sportpharm LLC, effective April 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →