NDC 68462-727
Saxagliptin 5 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 # 17232460, exp. date Nov-25 17232460, exp. date Nov-25 17241194, exp. date Jun-26 17241194, exp. date Jun-26 - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: 30-Count Bottle Lots: 17241788, exp. date Sep-26 17241821, exp. date Sep-26 17241822, exp. date Sep-26 90-Count Bottle Lot: 17241822, exp. date Sept 26
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Saxagliptin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA205994
- On the market since
- Jul 31, 2023
- Package NDCs
68462-727-0568462-727-1468462-727-3068462-727-90- Official label
- DailyMed (National Library of Medicine), updated Jan 27, 2026
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