NDC 68258-1104
Atovaquone and Proguanil Hydrochloride 100 mg / 250 mg tablet, film coated
On the label: Dispensing Solutions Inc.. It's repackaged: Dispensing Solutions 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
- Dispensing Solutions Inc., Santa Ana, California, United States · repackages it and relabels 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
- Aug 18, 2011
- Package NDCs
68258-1104-368258-1104-468258-1104-568258-1104-668258-1104-768258-1104-9- Official label
- DailyMed (National Library of Medicine), updated Aug 23, 2013
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