NDC 61919-790
Valsartan/Htcz 160 mg / 12.5 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Macleods Pharmaceuticals Limited's NDC 33342-075.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Macleods Pharmaceuticals Limited | District Solan, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 20, 2023 · 6 inspections, 2 with FDA action |
| Macleods Pharmaceuticals Limited | Daman, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMay 26, 2023 · 4 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Hydrochlorothiazide and Valsartan: every company that makes it
- Form
- tablet, film coated
- Strength
- 160 mg / 12.5 mg
- Approval
- ANDA ANDA203145
- On the market since
- Apr 9, 2019
- Package NDCs
61919-790-30- Official label
- DailyMed (National Library of Medicine), updated Sep 20, 2023
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