NDC 57894-503
Darzalex Faspro 1800 mg per 15 mL / 30000 U per 15 mL injection
On the label: Janssen Biotech, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Catalent Indiana, LLC | Bloomington, IN, United States | Makes the active ingredient | Serious problems, FDA actionApr 24, 2026 · 10 inspections, 2 with FDA action |
| Cilag AG | Schaffhausen, Switzerland | Makes it, tests it, packages it and labels it | No problems foundNov 21, 2025 · 8 inspections |
| FUJIFILM Diosynth Biotechnologies Denmark ApS | Hillerod, Denmark | Makes the active ingredient | Problems found, fixed voluntarilyJun 30, 2023 · 5 inspections |
| Janssen Biotech, Inc. | Malvern, PA, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJul 29, 2025 · 13 inspections |
| Lonza AG | Visp, Switzerland | Makes it and tests it | Not inspected on record |
| Bioreliance Corporation | Rockville, MD, United States | Tests it | Problems found, fixed voluntarilyJan 29, 2026 · 7 inspections |
| Charles River Laboratories, Inc. | Malvern, PA, United States | Tests it | No problems foundJan 20, 2026 · 6 inspections |
| Eurofins Lancaster Laboratories, LLC | Lancaster, PA, United States | Tests it | Problems found, fixed voluntarilyAug 26, 2025 · 8 inspections |
| Janssen Biologics B.V. | Leiden, Netherlands | Tests it | Problems found, fixed voluntarilyJun 1, 2023 · 7 inspections |
| Janssen Pharmaceutica NV | Beerse, Belgium | Packages it | Problems found, fixed voluntarilySep 5, 2025 · 8 inspections |
| Janssen Sciences Ireland UC | CO Cork, Ireland | Tests it | Problems found, fixed voluntarilyJan 12, 2024 · 5 inspections |
| Lonza AG | Visp, Switzerland | Tests it | Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections |
Product details
- Generic drug
- Daratumumab and Hyaluronidase (human Recombinant): every company that makes it
- Form
- injection, subcutaneous
- Strength
- 1800 mg per 15 mL / 30000 U per 15 mL
- Approval
- BLA BLA761145
- On the market since
- May 1, 2020
- Package NDCs
57894-503-01- Official label
- DailyMed (National Library of Medicine), updated Oct 12, 2026
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