NDC 43063-393
Atovaquone and Proguanil Hydrochloride 100 mg / 250 mg tablet, film coated
On the label: PD-Rx Pharmaceuticals, Inc.. It's repackaged: PD-Rx Pharmaceuticals, Inc. rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-404.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | Monroe, NC, United States | Makes it and tests it | Problems found, fixed voluntarilyJun 17, 2025 · 2 inspections, 1 with FDA action |
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Repackaging site
- PD-Rx Pharmaceuticals Inc., Oklahoma City, OK, United States · repackages it
Product details
- Generic drug
- Atovaquone and Proguanil: every company that makes it
- Form
- tablet, film coated
- Strength
- 100 mg / 250 mg
- Approval
- ANDA ANDA091211
- On the market since
- Sep 15, 2011
- Package NDCs
43063-393-1443063-393-20- Official label
- DailyMed (National Library of Medicine), updated Oct 10, 2024
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