Prescription drug · NDA
Xofluza (Baloxavir marboxil) NDC 85766-058
Baloxavir marboxil 80 mg/1 · Tablet, Film coated · Oral · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-058-01 | 85766005801 | 1 BLISTER PACK in 1 CARTON (85766-058-01) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 22, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Xofluza
- Generic name (nonproprietary)
- baloxavir marboxil
- Active ingredients
- Baloxavir marboxil — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sportpharm LLCNDC labeler code 85766
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210854
- Marketing start
- Listing expires
- Other FDA classes
- Chelating Activity (Mechanism)Polymerase Acidic Endonuclease Inhibitors (Mechanism)
- Identifiers
- Product ID 85766-058_502f0591-7637-2e7b-e063-6294a90a6e98SPL ID 502f0591-7637-2e7b-e063-6294a90a6e98SPL set ID b58b2899-4d22-41e1-8f0c-bdead8917694RxCUI 2536740, 2536742UNII 505CXM6OHG
- Pharmacologic class
- Polymerase Acidic Endonuclease Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485766005801followed by a unit qualifier and the quantityPackage 85766-0058-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the 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 . ( 1.1 ) Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. ( 1.2 ) Limitations of Use Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available inf…
Excerpt only. Read the full label for complete information.
About NDC 85766-058
- What is NDC 85766-058?
- 85766-058 is the product NDC for Xofluza (baloxavir marboxil), Baloxavir marboxil 80 mg/1 tablet, film coated, listed with the FDA by Sportpharm LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xofluza (Baloxavir marboxil).
- What is the active ingredient?
- Baloxavir marboxil.
- Who is the labeler?
- Sportpharm LLC, NDC labeler code 85766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xofluza?
- 5 other product NDCs are listed under this name. See all Xofluza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xofluza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xofluzabaloxavir marboxil | Baloxavir marboxil 30 mg/1 | Granule, For suspensionOral | Genentech, Inc. | 50242-599 | 50242-0599-01 |
| Xofluzabaloxavir marboxil | Baloxavir marboxil 40 mg/1 | Granule, For suspensionOral | Genentech, Inc. | 50242-617 | 50242-0617-01 |
| Xofluzabaloxavir marboxil | Baloxavir marboxil 40 mg/20mL | Granule, For solutionOral | Genentech, Inc. | 50242-583 | 50242-0583-01 |
| Xofluzabaloxavir marboxil | Baloxavir marboxil 40 mg/1 | Tablet, Film coatedOral | Genentech, Inc. | 50242-860 | 50242-0860-0150242-0860-86 |
| Xofluzabaloxavir marboxil | Baloxavir marboxil 80 mg/1 | Tablet, Film coatedOral | Genentech, Inc. | 50242-877 | 50242-0877-0150242-0877-86 |
Other NDCs under NDA 210854
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Xofluzabaloxavir marboxil | Baloxavir marboxil 40 mg/1 | Tablet, Film coatedOral | Genentech, Inc. | 50242-860 |
| Xofluzabaloxavir marboxil | Baloxavir marboxil 80 mg/1 | Tablet, Film coatedOral | Genentech, Inc. | 50242-877 |