NDC 61919-493
Fluconazole 200 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 70710-1140.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
| Zydus Lifesciences Limited | Solan, India | Makes it and tests it | No problems foundMar 9, 2020 · 6 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Fluconazole: every company that makes it
- Form
- tablet, oral
- Strength
- 200 mg
- Approval
- ANDA ANDA208963
- On the market since
- Apr 8, 2019
- Package NDCs
61919-493-03- Official label
- DailyMed (National Library of Medicine), updated Jan 9, 2024
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