Xofluza

Manufacturer: Evonik Corporation
Effective date: 2022-06-28
Label type: BULK INGREDIENT
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 21:57:57

Label at a glance#

ProductXofluza

Active ingredientBALOXAVIR MARBOXIL

Label structure3 sections

Contacts and useful links#

PhoneLabel contact765-477-4300

PhoneLabel contact765-477-4291

PhoneLabel contact800-424-9300

Label contents#

Full prescribing information#

Drum Label, Baloxavir marboxil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Caution: For manufacturing, processing or repacking. Rx only.

EV022X

S-033188 API Milled

Baloxavir Marboxil (DOP13)

Caution: LIver, Potent, Suspect Reproductive

Storage conditions: 1 - 30 C

Batch number:

Manufacture Date:

Manufactured and tested by Evonik Corporation, Tippecanoe Laboratories, 1650 Lilly Road, Lafayette, IN 47909

Baloxavir Marboxil

Warehouse put-away label, net weight

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product is weighed in the warehouse and the weight is on this label. Label also includes the storage location (in the warehouse) and the SAP transfer order#.

Material number : EV022X

Material description:

Batch:

TO:

SU: storage unit

Quantity: x.xx Kg

Generic warehouse Kg label

May 2022 Warehouse KG label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

S-033188 API Milled

Put-Away Label

Material Number 99144221

Storage Unit

Net Weight xx Kg

Lot/Batch

Old Material Number EV022X

QR code box

Temperature Conditions: 1 to 30°C

Hazards:

Liver Potent Suspect Reproductive

Health (U) Unknown

Fire (U) Unknown

Reactivity (U) Unknown

Special P (highly potent)

Evonik Corporation

1650 Lilly Road Lafayette, Indiana 47909 USA

Phone: 765-477-4300 Fax: 765-477-4291

Evonik: Leading beyond Chemistry

Emergency Information: Chemtrec 800-424-9300

Warehouse_KG_May2022

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Xofluza
Baloxavir marboxil

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62128-0394	62128-0394-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BALOXAVIR MARBOXIL	505CXM6OHG	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xofluza	BALOXAVIR MARBOXIL	Sportpharm LLC	b58b2899-4d22-41e1-8f0c-bdead8917694	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Xofluza generic name: BALOXAVIR MARBOXIL
Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	e49e1a61-1b7c-4be5-ac84-af6240b511e7	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Xofluza generic name: BALOXAVIR MARBOXIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.