NDC 63187-653
Irbesartan and Hydrochlorothiazide 150 mg / 12.5 mg tablet, film coated
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Macleods Pharmaceuticals Limited's NDC 33342-057.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Macleods Pharmaceuticals Limited | Daman, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMay 26, 2023 · 4 inspections |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it
Product details
- Generic drug
- Hydrochlorothiazide and Irbesartan: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 150 mg / 12.5 mg
- Approval
- ANDA ANDA202414
- On the market since
- Sep 27, 2012
- Package NDCs
63187-653-3063187-653-6063187-653-90- Official label
- DailyMed (National Library of Medicine), updated Jan 1, 2021
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