NDC 16729-397
isosorbide mononitrate 60 mg tablet, extended release
On the label: Accord Healthcare Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Isosorbide Mononitrate: every company that makes it
- Form
- tablet, extended release
- Strength
- 60 mg
- Approval
- ANDA ANDA209684
- On the market since
- Jan 1, 2025
- Package NDCs
16729-397-0116729-397-1516729-397-1616729-397-17- Official label
- DailyMed (National Library of Medicine), updated Feb 1, 2023
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