Xofluza
- Product NDC
- 50242-617
- 11-digit product format
- 502420617
- Labeler code
- 50242
- Product ID
- 50242-617_c2da90f4-a11c-46d2-be18-53d286b084cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baloxavir Marboxil
- Dosage form
- GRANULE, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Genentech, Inc.
- Application
- NDA214410
- Marketing category
- NDA
- Marketing start
- 2025-05-30
- Substance
- BALOXAVIR MARBOXIL
- Active strength
- 40 mg/1
- Pharmacologic classes
- Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 505CXM6OHG | BALOXAVIR MARBOXIL | 1985606-14-1 | BALOXAVIR MARBOXIL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-617-01 | 50242061701 | 1 PACKET in 1 CARTON (50242-617-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET | 1 packet | 2025-05-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Xofluza | Genentech, Inc. | F. Hoffmann-La Roche Ltd. | F. Hoffmann-La Roche AG | 2025-12-15 | HUMAN PRESCRIPTION DRUG LABEL | 30 |