NDC 57894-160
Infliximab 100 mg per 10 mL injection, powder, lyophilized, for solution
On the label: Janssen Biotech, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cilag AG | Schaffhausen, Switzerland | Makes it, tests it and packages it | No problems foundNov 21, 2025 · 8 inspections |
| Hospira, Inc. | McPherson, KS, United States | Makes it and tests it | Problems found, fixed voluntarilyJan 17, 2025 · 16 inspections, 2 with FDA action |
| Janssen Biologics B.V. | Leiden, Netherlands | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJun 1, 2023 · 7 inspections |
| Janssen Biotech, Inc. | Malvern, PA, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJul 29, 2025 · 13 inspections |
| Janssen-Cilag Manufacturing, LLC | Gurabo, PR, United States | Makes it and tests it | Problems found, fixed voluntarilyFeb 11, 2026 · 6 inspections |
| Patheon Italia S.p.A. | Monza, Italy | Makes it | Problems found, fixed voluntarilyMay 26, 2023 · 10 inspections |
| AndersonBrecon Inc. | Rockford, IL, United States | Packages it | No problems foundAug 19, 2026 · 11 inspections |
Product details
- Generic drug
- Infliximab: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 100 mg per 10 mL
- Approval
- BLA BLA103772
- On the market since
- Oct 5, 2021
- Package NDCs
57894-160-01- Official label
- DailyMed (National Library of Medicine), updated Feb 11, 2026
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