NDC 42571-509
Sapropterin Dihydrochloride 100 mg powder, for solution
On the label: Micro Labs Limited.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Micro Labs Limited | Verna, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMay 30, 2025 · 6 inspections, 1 with FDA action |
Product details
- Generic drug
- Sapropterin: every company that makes it
- Form
- powder, for solution, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA219511
- On the market since
- Apr 1, 2026
- Package NDCs
42571-509-3042571-509-41- Official label
- DailyMed (National Library of Medicine), updated Jan 14, 2026
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