NDC 67046-1059
Hydralazine Hydrochloride 50 mg tablet
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-521.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Annora Pharma Private Limited | Sangareddy, India | Makes it | Problems found, fixed voluntarilyMar 28, 2025 · 4 inspections |
| Hetero Labs Limited | Hyderabad, India | Makes it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
| Hetero Labs Limited | Hobli Vemagal Kolar, India | Makes it | No problems foundJan 31, 2025 · 1 inspection |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Product details
- Generic drug
- Hydralazine: every company that makes it
- Form
- tablet
- Strength
- 50 mg
- Approval
- ANDA ANDA040901
- On the market since
- Nov 8, 2024
- Package NDCs
67046-1059-3- Official label
- DailyMed (National Library of Medicine), updated Nov 8, 2024
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