NDC 67046-1446
Isosorbide Mononitrate 30 mg tablet, extended release
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Aurobindo Pharma Limited's NDC 59651-539.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Product details
- Generic drug
- Isosorbide Mononitrate: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 30 mg
- Approval
- ANDA ANDA216557
- On the market since
- Feb 7, 2025
- Package NDCs
67046-1446-3- Official label
- DailyMed (National Library of Medicine), updated Feb 7, 2025
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