NDC 50242-077
Herceptin Hylecta 600 mg per 5 mL / 10000 U per 5 mL injection, solution
On the label: Genentech, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| F. Hoffmann-La Roche AG | Kaiseraugst, Switzerland | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 21, 2025 · 8 inspections |
| Roche Diagnostics GmbH | Penzberg, Germany | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMay 22, 2025 · 6 inspections |
| Roche Singapore Technical Operations Pte. Ltd. | Singapore, Singapore | Makes the active ingredient and tests it | Problems found, fixed voluntarilyNov 14, 2025 · 6 inspections |
| Genentech, Inc. | South San Francisco, CA, United States | Tests it | No problems foundMay 15, 2026 · 37 inspections |
| Genentech, Inc. | Oceanside, CA, United States | Tests it | No problems foundAug 16, 2024 · 5 inspections |
| Roche Diagnostics GmbH | Mannheim, Germany | Tests it | Problems found, fixed voluntarilyOct 29, 2021 · 5 inspections |
Product details
- Generic drug
- Hyaluronidase (human Recombinant) and Trastuzumab: every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 600 mg per 5 mL / 10000 U per 5 mL
- Approval
- BLA BLA761106
- On the market since
- Feb 28, 2019
- Package NDCs
50242-077-01- Official label
- DailyMed (National Library of Medicine), updated Sep 22, 2026
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