NDC 68462-573
voriconazole 200 mg tablet, film coated
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17230853, exp. date Mar-25 17231271, exp. date May-25 17231300, exp. date May-25 17242050, exp. date Oct-26 17231046, exp. date Apr-25 17241156, exp. date Jun-26 17241388, exp. date Jul-26 17241800, exp. date Sep-26 - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17231045, exp. date Apr-25
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Voriconazole: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 200 mg
- Approval
- ANDA ANDA203503
- On the market since
- Sep 4, 2015
- Package NDCs
68462-573-1368462-573-3068462-573-90- Official label
- DailyMed (National Library of Medicine), updated Aug 20, 2025
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