Xofluza is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Baloxavir Marboxil.
Product ID | 50090-4102_70777ca8-f814-4874-9b8b-c1cb5693d1df |
NDC | 50090-4102 |
Product Type | Human Prescription Drug |
Proprietary Name | Xofluza |
Generic Name | Baloxavir Marboxil |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2018-10-24 |
Marketing Category | NDA / NDA |
Application Number | NDA210854 |
Labeler Name | A-S Medication Solutions |
Substance Name | BALOXAVIR MARBOXIL |
Active Ingredient Strength | 20 mg/1 |
Pharm Classes | Polymerase Acidic Endonuclease Inhibitor [EPC],Polymerase Acidic Endonuclease Inhibitors [MoA],Chelating Activity [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2019-01-29 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA210854 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-01-29 |
Ingredient | Strength |
---|---|
BALOXAVIR MARBOXIL | 20 mg/1 |
SPL SET ID: | e9e6990a-66d3-4e13-b823-ff04d2d65886 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
50090-4102 | Xofluza | BALOXAVIR MARBOXIL |
50090-4104 | Xofluza | BALOXAVIR MARBOXIL |
50242-583 | Xofluza | BALOXAVIR MARBOXIL |
50242-828 | Xofluza | BALOXAVIR MARBOXIL |
50242-860 | Xofluza | BALOXAVIR MARBOXIL |
50242-877 | Xofluza | BALOXAVIR MARBOXIL |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XOFLUZA 90777855 not registered Live/Pending |
Genentech, Inc. 2021-06-16 |
XOFLUZA 87920532 not registered Live/Pending |
Genentech, Inc. 2018-05-14 |
XOFLUZA 87762294 not registered Live/Pending |
Shionogi & Co., Ltd. 2018-01-19 |