Xofluza
- Product NDC
- 50242-828
- 11-digit product format
- 502420828
- Labeler code
- 50242
- Product ID
- 50242-828_9fff47fc-18e0-4f9c-b0a6-8ec83b2ee449
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BALOXAVIR MARBOXIL
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Genentech, Inc.
- Application
- NDA210854
- Marketing category
- NDA
- Marketing start
- 2018-10-24
- Marketing end
- 2022-07-31
- Substance
- BALOXAVIR MARBOXIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e77882ec-c16a-4b71-b3f9-3d7ef83d1aed | Product name | 2 | 20260310 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50242-828-02 | EA - Each | 50242-828 | f8a74ea7-196a-4289-b559-ab260f01f1cc | 1 | 2018-11-06 |
| 50242-828-86 | EA - Each | 50242-828 | 2bf0574c-d4fb-4978-88f5-c5f5072cb81c | 1 | 2019-03-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2100099 | {2 (baloxavir marboxil 20 MG Oral Tablet [Xofluza]) } Pack [Xofluza 40 MG Dose Pack (2 x 20 MG Tablets)] | BPCK | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
| 2100024 | {2 (baloxavir marboxil 20 MG Oral Tablet) } Pack | GPCK | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
| 2100000 | baloxavir marboxil 20 MG Oral Tablet | PSN | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
| 2100024 | baloxavir marboxil 40 MG Dose Pack (2 x 20 MG Tablets) | PSN | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
| 2100006 | Xofluza 20 MG Oral Tablet | PSN | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
| 2100099 | Xofluza 40 MG Dose Pack (2 x 20 MG Tablets) | PSN | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
| 2100006 | baloxavir marboxil 20 MG Oral Tablet [Xofluza] | SBD | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
| 2100000 | baloxavir marboxil 20 MG Oral Tablet | SCD | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
| 2100024 | baloxavir marboxil 40 MG Dose Pack (2 x 20 MG Tablets) | SY | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
| 2100006 | Xofluza 20 MG Oral Tablet | SY | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
| 2100099 | Xofluza 40 MG Dose Pack (2 x 20 MG Tablets) | SY | e9e6990a-66d3-4e13-b823-ff04d2d65886 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50242-828-02 | 50242082802 | 1 BLISTER PACK in 1 CARTON (50242-828-02) > 2 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2018-10-24 | 2022-07-31 | No | No | Current |
| 50242-828-86 | 50242082886 | 1 BLISTER PACK in 1 CARTON (50242-828-86) > 2 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2018-10-24 | 2022-07-31 | Yes | No | Current |