NDC 50090-4104

Xofluza

Baloxavir Marboxil

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: 50090-4104_5cb93fbe-c776-4766-8dbb-e21af005eec1
• NDC: 50090-4104
• 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: 40 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

Packaging

NDC 50090-4104-0

1 BLISTER PACK in 1 CARTON (50090-4104-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2019-01-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-4104-0 [50090410400]

Xofluza TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210854
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-29

Drug Details

Active Ingredients

Ingredient	Strength
BALOXAVIR MARBOXIL	40 mg/1

OpenFDA Data

• SPL SET ID: 325b077a-8fe2-435c-be70-df9579862e13
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 505CXM6OHG
• RxNorm Concept Unique ID - RxCUI:
  • 2100008
  • 2100100
  • 2100010
  • 2100026

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