NDC 53808-0773
Prezista 600 mg tablet, film coated
On the label: State of Florida DOH Central Pharmacy. It's repackaged: State of Florida DOH Central Pharmacy rebottles it from Janssen Products LP's NDC 59676-562.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cilag AG | Schaffhausen, Switzerland | Makes the active ingredient | No problems foundNov 21, 2025 · 8 inspections |
| Janssen Cilag SpA | Borgo San Michele, Italy | Makes it and tests it | Problems found, fixed voluntarilySep 27, 2024 · 6 inspections |
| Janssen Ortho LLC | Gurabo, PR, United States | Makes it and tests it | Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections |
| Janssen Pharmaceutical Sciences Unlimited Company | Co Cork, Ireland | Makes the active ingredient | Problems found, fixed voluntarilyOct 27, 2023 · 5 inspections |
| Porton Pharma Solutions Ltd | Chongqing, China | Makes the active ingredient | No problems foundMar 29, 2024 · 3 inspections |
| Thermo Fisher Scientific Cork Limited | Carrigaline, Ireland | Makes the active ingredient | Problems found, fixed voluntarilySep 7, 2022 · 6 inspections, 1 with FDA action |
| Janssen Pharmaceuticals, Inc. | Titusville, NJ, United States | Tests it | Problems found, fixed voluntarilySep 25, 2026 · 11 inspections |
Product details
- Generic drug
- Darunavir: every company that makes it
- Form
- tablet, film coated
- Strength
- 600 mg
- Approval
- NDA NDA021976
- On the market since
- Jul 1, 2009
- Package NDCs
53808-0773-1- Official label
- DailyMed (National Library of Medicine), updated Aug 23, 2010
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