Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cambrex Profarmaco Milano SRL | Paullo, Italy | Makes the active ingredient and tests it | No problems foundNov 11, 2022 · 7 inspections, 1 with FDA action |
| EUROAPI Hungary Ltd. | Budapest, Hungary | Makes the active ingredient and tests it | No problems foundJun 21, 2019 · 4 inspections |
| Sanofi Winthrop Industrie | Ambares Et Lagrave, France | Makes it and tests it | Problems found, fixed voluntarilyNov 22, 2023 · 5 inspections |
| Sanofi Winthrop Industrie | Aramon, France | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 10, 2023 · 6 inspections |
| Eurofins Lancaster Laboratories, LLC | Lancaster, PA, United States | Tests it | Problems found, fixed voluntarilyAug 26, 2025 · 8 inspections |
| Sanofi Winthrop Industrie | Tours, France | Packages it and labels it | Problems found, fixed voluntarilyJan 27, 2023 · 6 inspections |
Product details
- Generic drug
- Hydrochlorothiazide and Irbesartan: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 150 mg / 12.5 mg
- Approval
- NDA NDA020758
- On the market since
- Jan 1, 2013
- Package NDCs
0024-5855-300024-5855-90- Official label
- DailyMed (National Library of Medicine), updated Oct 7, 2025
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