NDC 58394-016
Xyntha 70 mL per 100 mL / 3000 [iU] per 4 mL kit
On the label: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pfizer Ireland Pharmaceuticals Unlimited Company | Dublin, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyDec 15, 2023 · 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
- Isopropyl Alcohol and Moroctocog Alfa: every company that makes it
- Form
- kit
- Strength
- 70 mL per 100 mL / 3000 [iU] per 4 mL
- Approval
- BLA BLA125264
- On the market since
- Aug 13, 2010
- Package NDCs
58394-016-0358394-116-03- Official label
- DailyMed (National Library of Medicine), updated Mar 16, 2026
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