Xofluza
- Product NDC
- 85766-058
- 11-digit product format
- 857660058
- Labeler code
- 85766
- Product ID
- 85766-058_502f0591-7637-2e7b-e063-6294a90a6e98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BALOXAVIR MARBOXIL
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- NDA210854
- Marketing category
- NDA
- Marketing start
- 2018-10-24
- Substance
- BALOXAVIR MARBOXIL
- Active strength
- 80 mg/1
- Pharmacologic classes
- Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xofluza
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BALOXAVIR MARBOXIL | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 505CXM6OHG |
| Rxcui | 2536740, 2536742 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85766-058-01 | Xofluza | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 2 |
| 85766-058-01 | Xofluza | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-058-01 | 85766005801 | 1 BLISTER PACK in 1 CARTON (85766-058-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2025-08-22 | No | No | Historical |