NDC 53002-1632
Lutera 0.1 mg / 0.02 mg kit
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Mayne Pharma Inc.'s NDC 51862-028.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Patheon Inc. | Mississauga, Canada | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 24, 2023 · 7 inspections |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Product details
- Generic drug
- Ethinyl Estradiol and Levonorgestrel: every company that makes it
- Form
- kit
- Strength
- 0.1 mg / 0.02 mg
- Approval
- ANDA ANDA076625
- On the market since
- Aug 3, 2016
- Package NDCs
53002-1632-153002-1632-353002-1632-6- Official label
- DailyMed (National Library of Medicine), updated Dec 15, 2020
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