Xofluza
- Product NDC
- 50090-4104
- 11-digit product format
- 500904104
- Labeler code
- 50090
- Product ID
- 50090-4104_dd56a138-b947-4413-8098-c65e5a6de200
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BALOXAVIR MARBOXIL
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA210854
- Marketing category
- NDA
- Marketing start
- 2018-10-24
- Marketing end
- 0000-00-00
- Substance
- BALOXAVIR MARBOXIL
- Active strength
- 40 mg/1
- Pharmacologic classes
- Polymerase Acidic Endonuclease Inhibitor [EPC],Polymerase Acidic Endonuclease Inhibitors [MoA],Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e77882ec-c16a-4b71-b3f9-3d7ef83d1aed | Product name | 2 | 20260310 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4104-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2011-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use XOFLUZA safely and effectively. See full prescribing information for XOFLUZA. XOFLUZA ® (baloxavir marboxil) tablets, for oral use XOFLUZA ® (baloxavir marboxil) for oral suspension Initial U.S. Approval: 2018 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4104-0 | Xofluza | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 5 | |
| 50090-4104-0 | Xofluza | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4104 | XOFLUZA (BALOXAVIR MARBOXIL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 5 | Legacy NDC, 2 package rows | 20210418_325b077a-8fe2-435c-be70-df9579862e13.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2100100 | {2 (baloxavir marboxil 40 MG Oral Tablet [Xofluza]) } Pack [Xofluza 80 MG Dose Pack (2 x 40 MG Tablets)] | BPCK | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
| 2100026 | {2 (baloxavir marboxil 40 MG Oral Tablet) } Pack | GPCK | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
| 2100008 | baloxavir marboxil 40 MG Oral Tablet | PSN | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
| 2100026 | baloxavir marboxil 80 MG Dose Pack (2 x 40 MG Tablets) | PSN | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
| 2100010 | Xofluza 40 MG Oral Tablet | PSN | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
| 2100100 | Xofluza 80 MG Dose Pack (2 x 40 MG Tablets) | PSN | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
| 2100010 | baloxavir marboxil 40 MG Oral Tablet [Xofluza] | SBD | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
| 2100008 | baloxavir marboxil 40 MG Oral Tablet | SCD | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
| 2100026 | baloxavir marboxil 80 MG Dose Pack (2 x 40 MG Tablets) | SY | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
| 2100010 | Xofluza 40 MG Oral Tablet | SY | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
| 2100100 | Xofluza 80 MG Dose Pack (2 x 40 MG Tablets) | SY | 325b077a-8fe2-435c-be70-df9579862e13 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4104-0 | 50090410400 | 1 BLISTER PACK in 1 CARTON (50090-4104-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2019-01-29 | 0000-00-00 | No | No | Current |