NDC 53002-1777
VyLibra 0.035 mg / 0.250 mg kit
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Afaxys Pharma LLC's NDC 50102-235.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · relabels it
Product details
- Generic drug
- Ethinyl Estradiol and Norgestimate: every company that makes it
- Form
- kit
- Strength
- 0.035 mg / 0.250 mg
- Approval
- ANDA ANDA205449
- On the market since
- Jul 7, 2016
- Package NDCs
53002-1777-153002-1777-353002-1777-6- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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