xofluza

Generic: baloxavir marboxil

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xofluza
Generic Name baloxavir marboxil
Labeler genentech, inc.
Dosage Form GRANULE, FOR SOLUTION
Routes
ORAL
Active Ingredients

baloxavir marboxil 40 mg/20mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-583
Product ID 50242-583_c2da90f4-a11c-46d2-be18-53d286b084cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214410
Listing Expiration 2026-12-31
Marketing Start 2018-10-24

Pharmacologic Class

Classes
chelating activity [moa] polymerase acidic endonuclease inhibitor [epc] polymerase acidic endonuclease inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242583
Hyphenated Format 50242-583

Supplemental Identifiers

RxCUI
2100008 2100010 2467537 2467539 2536740 2536742 2716798 2716800
UNII
505CXM6OHG

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xofluza (source: ndc)
Generic Name baloxavir marboxil (source: ndc)
Application Number NDA214410 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (50242-583-01) / 20 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

50242-583-01 1 BOTTLE, GLASS in 1 CARTON (50242-583-01) / 20 mL in 1 BOTTLE, GLASS

Ingredients (1)

baloxavir marboxil (40 mg/20mL)

Linked Drug Pages (1)

Xofluza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c2da90f4-a11c-46d2-be18-53d286b084cf", "openfda": {"unii": ["505CXM6OHG"], "rxcui": ["2100008", "2100010", "2467537", "2467539", "2536740", "2536742", "2716798", "2716800"], "spl_set_id": ["e49e1a61-1b7c-4be5-ac84-af6240b511e7"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (50242-583-01)  / 20 mL in 1 BOTTLE, GLASS", "package_ndc": "50242-583-01", "marketing_start_date": "20201123"}], "brand_name": "Xofluza", "product_id": "50242-583_c2da90f4-a11c-46d2-be18-53d286b084cf", "dosage_form": "GRANULE, FOR SOLUTION", "pharm_class": ["Chelating Activity [MoA]", "Polymerase Acidic Endonuclease Inhibitor [EPC]", "Polymerase Acidic Endonuclease Inhibitors [MoA]"], "product_ndc": "50242-583", "generic_name": "BALOXAVIR MARBOXIL", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xofluza", "active_ingredients": [{"name": "BALOXAVIR MARBOXIL", "strength": "40 mg/20mL"}], "application_number": "NDA214410", "marketing_category": "NDA", "marketing_start_date": "20181024", "listing_expiration_date": "20261231"}