NDC 68462-264
Rosuvastatin calcium 40 mg tablet, film coated
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's 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 |
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17240389, exp. date Feb-26 17240390, exp. date Feb-26 17240426, exp. date Feb-26 17240427, exp. date Feb-26 17240428, exp. date Feb-26 17240778, exp. date Apr-26 17241055, exp. date May-26 17241074, exp. date Jun-26 17241075, exp. date Jun-26 17241091, exp. date Jun-26 17241100, exp. date…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Rosuvastatin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA079172
- On the market since
- Jul 19, 2016
- Package NDCs
68462-264-0168462-264-0568462-264-1068462-264-3068462-264-5068462-264-90- Official label
- DailyMed (National Library of Medicine), updated Aug 7, 2026
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