NDC 0054-0906
sapropterin dihydrochloride 100 mg tablet
On the label: Hikma Pharmaceuticals USA Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zenara Pharma Private Limited | Hyderabad, India | Makes it | Problems found, fixed voluntarilyMay 21, 2024 · 1 inspection |
Product details
- Generic drug
- Sapropterin: every company that makes it
- Form
- tablet, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA218797
- On the market since
- Oct 23, 2025
- Package NDCs
0054-0906-23- Official label
- DailyMed (National Library of Medicine), updated Aug 6, 2026
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