NDC 0597-0164
Glyxambi 5 mg / 25 mg tablet, film coated
On the label: Boehringer Ingelheim Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Boehringer Ingelheim Pharma GmbH and Co. KG | Ingelheim am Rhein, Germany | Makes it, makes the active ingredient, packages it and labels it | Problems found, fixed voluntarilyMay 15, 2025 · 8 inspections, 1 with FDA action |
| Rottendorf Pharma GmbH | Ennigerloh, Germany | Makes it, packages it and labels it | Problems found, fixed voluntarilyMar 14, 2024 · 6 inspections |
| Sixarp, LLC | Grand Rapids, MI, United States | Packages it and labels it | No problems foundMar 6, 2025 · 4 inspections |
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 3513
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Empagliflozin and Linagliptin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 5 mg / 25 mg
- Approval
- NDA NDA206073
- On the market since
- Jan 30, 2015
- Package NDCs
0597-0164-070597-0164-300597-0164-390597-0164-700597-0164-90- Official label
- DailyMed (National Library of Medicine), updated Jan 20, 2026
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