NDC 59676-578

Prezcobix 150 mg / 675 mg tablet, film coated

On the label: Janssen Products LP.

Ireland: 2Canada: 1China: 1South Korea: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Janssen Pharmaceutical Sciences Unlimited CompanyCo Cork, IrelandMakes the active ingredient Problems found, fixed voluntarilyOct 27, 2023 · 5 inspections
Patheon Inc.Mississauga, CanadaMakes it and packages it Problems found, fixed voluntarilyFeb 24, 2023 · 7 inspections
Porton Pharma Solutions LtdChongqing, ChinaMakes the active ingredient No problems foundMar 29, 2024 · 3 inspections
Thermo Fisher Scientific Cork LimitedCarrigaline, IrelandMakes the active ingredient Problems found, fixed voluntarilySep 7, 2022 · 6 inspections, 1 with FDA action
Yuhan Chemical Inc.Ansan-si, South KoreaMakes the active ingredient Problems found, fixed voluntarilyFeb 28, 2025 · 6 inspections
Janssen Ortho LLCGurabo, PR, United StatesTests it Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections

Product details

Generic drug
Cobicistat and Darunavir: every company that makes it
Form
tablet, film coated, oral
Strength
150 mg / 675 mg
Approval
NDA NDA205395
On the market since
Mar 21, 2025
Package NDCs
59676-578-30
Official label
DailyMed (National Library of Medicine), updated Feb 1, 2026

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