NDC 50242-828

Xofluza

Baloxavir Marboxil

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

• Product ID: 50242-828_182ac3b1-b615-478d-9762-5ce874368e9a
• NDC: 50242-828
• 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: Genentech, Inc
• 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: 2020-12-31

Packaging

NDC 50242-828-02

1 BLISTER PACK in 1 CARTON (50242-828-02) > 2 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2018-10-24
• Marketing End Date: 2022-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-828-02 [50242082802]

Xofluza TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210854
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-24

NDC 50242-828-86 [50242082886]

Xofluza TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210854
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-24

Drug Details

Active Ingredients

Ingredient	Strength
BALOXAVIR MARBOXIL	20 mg/1

OpenFDA Data

• SPL SET ID: e49e1a61-1b7c-4be5-ac84-af6240b511e7
• Manufacturer:
  • Genentech, Inc
• UNII:
  • 505CXM6OHG
• RxNorm Concept Unique ID - RxCUI:
  • 2100099
  • 2100100
  • 2100024
  • 2100026
  • 2100000
  • 2100006
  • 2100010
  • 2100008

Medicade Reported Pricing

50242082802 XOFLUZA 20 MG TAB (40 MG DOSE)

Pricing Unit: EA | Drug Type:

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