NDC 55154-1424
Xarelto 15 mg tablet, film coated
On the label: Cardinal Health 107, LLC. It's repackaged: Cardinal Health 107, LLC rebottles it from Janssen Pharmaceuticals, Inc.'s NDC 50458-578.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bayer AG | Leverkusen, Germany | Makes the active ingredient | Problems found, fixed voluntarilyMar 20, 2025 · 10 inspections, 2 with FDA action |
| Janssen Ortho LLC | Gurabo, PR, United States | Makes it and tests it | Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections |
| Lusomedicamenta - Sociedade Tecnica Farmaceutica, S.a. | Queluz de Baixo, Portugal | Makes it | Problems found, fixed voluntarilyOct 18, 2024 · 2 inspections |
| AndersonBrecon Inc. | Rockford, IL, United States | Packages it | No problems foundAug 19, 2026 · 11 inspections |
| Bayer AG | Bergkamen, Germany | Tests it | Problems found, fixed voluntarilyNov 14, 2024 · 7 inspections, 1 with FDA action |
Recalls
- Sep 17, 2014 · Class II · Janssen Ortho L.L.C.
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Lots: Lot 13JG2616 Exp. 07/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Rivaroxaban: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 15 mg
- Approval
- NDA NDA022406
- On the market since
- Nov 4, 2011
- Package NDCs
55154-1424-8- Official label
- DailyMed (National Library of Medicine), updated Aug 12, 2026
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