NDC 57894-502
Darzalex 100 mg per 5 mL injection, solution, concentrate
On the label: Janssen Biotech, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Biogen MA Inc. | Morrisville, NC, United States | Makes the active ingredient | No problems foundJun 13, 2018 · 9 inspections |
| Cilag AG | Schaffhausen, Switzerland | Makes it, tests it, packages it and labels it | No problems foundNov 21, 2025 · 8 inspections |
| Samsung Biologics Co., Ltd. | Incheon, South Korea | Makes the active ingredient and tests it | Problems found, fixed voluntarilySep 1, 2023 · 3 inspections |
| Simtra US LLC | Bloomington, IN, United States | Makes it, packages it and labels it | Problems found, fixed voluntarilySep 24, 2024 · 12 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | Ravensburg, Germany | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
| AndersonBrecon Inc. | Rockford, IL, United States | Packages it | No problems foundAug 19, 2026 · 11 inspections |
| Janssen Biologics B.V. | Leiden, Netherlands | Tests it | Problems found, fixed voluntarilyJun 1, 2023 · 7 inspections |
| Janssen Biotech, Inc. | Malvern, PA, United States | Tests it | Problems found, fixed voluntarilyJul 29, 2025 · 13 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 |
| PPD Development Ireland Ltd. | Athlone, Ireland | Tests it | Problems found, fixed voluntarilyMar 9, 2023 · 4 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Langenargen, Germany | Tests it | Problems found, fixed voluntarilyMar 20, 2024 · 8 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse) | Ravensburg, Germany | Tests it | Problems found, fixed voluntarilyJul 27, 2022 · 6 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Ravensburg, Germany | Tests it | Problems found, fixed voluntarilyJul 13, 2022 · 10 inspections |
Product details
- Generic drug
- Daratumumab: every company that makes it
- Form
- injection, solution, concentrate, intravenous
- Strength
- 100 mg per 5 mL
- Approval
- BLA BLA761036
- On the market since
- Nov 16, 2015
- Package NDCs
57894-502-0557894-502-20- Official label
- DailyMed (National Library of Medicine), updated Sep 21, 2026
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