NDC 67046-1619
Hydroxyurea 500 mg capsule
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Somerset Therapeutics, LLC's NDC 70069-820.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park) | Jinan, China | Makes it, tests it and packages it | Problems found, fixed voluntarilyMay 8, 2026 · 1 inspection |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Product details
- Generic drug
- Hydroxyurea: every company that makes it
- Form
- capsule, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA218021
- On the market since
- Dec 2, 2025
- Package NDCs
67046-1619-3- Official label
- DailyMed (National Library of Medicine), updated Dec 2, 2025
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