Xarelto

Cardinal Health 107, LLC🇺🇸 United States

FDA Page

Effective Date: Aug 12, 2026
Approval ID: d0e105f6-28f3-45ee-83bd-7d458835242b
Products: 3 registered
Version: 28

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use XARELTO safely and effectively. See full prescribing information for XARELTO. XARELTO (rivaroxaban) tablets, for oral use XARELTO (rivaroxaban) for oral suspension Initial U.S. Approval: 2011

Quick Stats

Total Products3

Labelers2

Label Sections22

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.