NDC 50419-424
Kyleena 19.5 mg intrauterine device
On the label: Bayer HealthCare Pharmaceuticals Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bayer AG | Bergkamen, Germany | Makes the active ingredient and tests it | Problems found, fixed voluntarilyNov 14, 2024 · 7 inspections, 1 with FDA action |
| Bayer Oy | Turku, Finland | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilySep 15, 2023 · 5 inspections |
| Bayer Aktiengesellschaft | Berlin, Germany | Tests it and mills it | Problems found, fixed voluntarilyJun 16, 2023 · 5 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it | No problems foundNov 21, 2025 · 7 inspections |
| Sterigenics Belgium (Petit Rechain) SRL | Verviers, Belgium | Sterilizes it | Problems found, fixed voluntarilyJun 29, 2023 · 3 inspections |
Product details
- Generic drug
- Levonorgestrel: every company that makes it
- Form
- intrauterine device, intrauterine
- Strength
- 19.5 mg
- Approval
- NDA NDA208224
- On the market since
- Sep 19, 2016
- Package NDCs
50419-424-0150419-424-0850419-424-71- Official label
- DailyMed (National Library of Medicine), updated Oct 23, 2025
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