NDC 50242-583

Xofluza

Baloxavir Marboxil

Xofluza is a Oral Granule, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Baloxavir Marboxil.

• Product ID: 50242-583_320baec8-003f-4970-9aa4-0210ab80a382
• NDC: 50242-583
• Product Type: Human Prescription Drug
• Proprietary Name: Xofluza
• Generic Name: Baloxavir Marboxil
• Dosage Form: Granule, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-24
• Marketing Category: NDA / NDA
• Application Number: NDA210854
• Labeler Name: Genentech, Inc.
• Substance Name: BALOXAVIR MARBOXIL
• Active Ingredient Strength: 40 mg/mL
• Pharm Classes: Polymerase Acidic Endonuclease Inhibitor [EPC],Polymerase Acidic Endonuclease Inhibitors [MoA],Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50242-583-01

1 BOTTLE, GLASS in 1 CARTON (50242-583-01) > 50 mL in 1 BOTTLE, GLASS

• Marketing Start Date: 2020-11-23
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "Xofluza" or generic name "Baloxavir Marboxil"

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