xofluza

Generic: baloxavir marboxil

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

Drug Facts

Product Profile

Brand Name xofluza
Generic Name baloxavir marboxil
Labeler sportpharm, inc. dba sportpharm
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

baloxavir marboxil 80 mg/1

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-058
Product ID 85766-058_3ceead88-93e3-1b77-e063-6394a90a46bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210854
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 85766058
Hyphenated Format 85766-058

Supplemental Identifiers

RxCUI
2536740 2536742
UNII
505CXM6OHG

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 NDA210854 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (85766-058-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

85766-058-01 1 BLISTER PACK in 1 CARTON (85766-058-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

baloxavir marboxil (80 mg/1)

Linked Drug Pages (1)

Xofluza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ceead88-93e3-1b77-e063-6394a90a46bd", "openfda": {"unii": ["505CXM6OHG"], "rxcui": ["2536740", "2536742"], "spl_set_id": ["b58b2899-4d22-41e1-8f0c-bdead8917694"], "manufacturer_name": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (85766-058-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "85766-058-01", "marketing_start_date": "20250822"}], "brand_name": "Xofluza", "product_id": "85766-058_3ceead88-93e3-1b77-e063-6394a90a46bd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Chelating Activity [MoA]", "Polymerase Acidic Endonuclease Inhibitor [EPC]", "Polymerase Acidic Endonuclease Inhibitors [MoA]"], "product_ndc": "85766-058", "generic_name": "BALOXAVIR MARBOXIL", "labeler_name": "Sportpharm, Inc. dba Sportpharm", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xofluza", "active_ingredients": [{"name": "BALOXAVIR MARBOXIL", "strength": "80 mg/1"}], "application_number": "NDA210854", "marketing_category": "NDA", "marketing_start_date": "20181024", "listing_expiration_date": "20261231"}