Active ingredient
Baloxavir Marboxil
6 finished FDA listings contain Baloxavir Marboxil as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BALOXAVIR MARBOXIL
- Dosage forms
- Granule, For Solution, Granule, For Suspension, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 30 mg/1 · 40 mg/1 · 40 mg/20ml · 80 mg/1
- Brand names in FDA listings
- Xofluza
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2099995
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 210854 | GENENTECH INC | 2018-10-24 | 3 |
| NDA 214410 | GENENTECH INC | 2020-11-23 | 3 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.