NDC 53002-2787
Valsartan and Hydrochlorothiazide 320 mg / 12.5 mg tablet, film coated
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Macleods Pharmaceuticals Limited's NDC 33342-077.
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
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Product details
- Generic drug
- Hydrochlorothiazide and Valsartan: every company that makes it
- Form
- tablet, film coated
- Strength
- 320 mg / 12.5 mg
- Approval
- ANDA ANDA203145
- On the market since
- Apr 19, 2013
- Package NDCs
53002-2787-9- Official label
- DailyMed (National Library of Medicine), updated Aug 18, 2023
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