NDC 65862-630
Irbesartan and Hydrochlorothiazide 300 mg / 12.5 mg tablet, film coated
On the label: Aurobindo Pharma Limited.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Hydrochlorothiazide and Irbesartan: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 300 mg / 12.5 mg
- Approval
- ANDA ANDA203630
- On the market since
- Feb 22, 2013
- Package NDCs
65862-630-0565862-630-3065862-630-9065862-630-99- Official label
- DailyMed (National Library of Medicine), updated Dec 19, 2025
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