NDC 61919-797
Losartan Potassium And Hydrochlorothiazide 100 mg / 12.5 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Aurobindo Pharma Limited's NDC 65862-469.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Mahabubnagar, India | Makes it and tests it | No problems foundJan 18, 2023 · 2 inspections |
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Hydrochlorothiazide and Losartan: every company that makes it
- Form
- tablet, film coated
- Strength
- 100 mg / 12.5 mg
- Approval
- ANDA ANDA091629
- On the market since
- Feb 5, 2019
- Package NDCs
61919-797-3061919-797-90- Official label
- DailyMed (National Library of Medicine), updated Oct 14, 2019
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