NDC 58394-635
BeneFIX 70 mL per 100 mL / 1000 [iU] per 5 mL kit
On the label: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Andover, MA, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyApr 8, 2026 · 5 inspections |
| Wyeth Farma SA | San Sebastian de los Reyes, Spain | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilySep 27, 2019 · 3 inspections |
Product details
- Generic drug
- Coagulation Factor Ix Recombinant Human and Isopropyl Alcohol: every company that makes it
- Form
- kit
- Strength
- 70 mL per 100 mL / 1000 [iU] per 5 mL
- Approval
- BLA BLA103677
- On the market since
- Feb 1, 1997
- Package NDCs
0069-1111-0158394-041-1158394-135-0358394-635-03- Official label
- DailyMed (National Library of Medicine), updated Feb 24, 2025
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