NDC 59676-563

Prezista 75 mg tablet, film coated

On the label: Janssen Products LP.

Ireland: 2Switzerland: 1Italy: 1United States: 1China: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Cilag AGSchaffhausen, SwitzerlandMakes the active ingredient No problems foundNov 21, 2025 · 8 inspections
Janssen Cilag SpABorgo San Michele, ItalyMakes it and tests it Problems found, fixed voluntarilySep 27, 2024 · 6 inspections
Janssen Ortho LLCGurabo, PR, United StatesMakes it and tests it Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections
Janssen Pharmaceutical Sciences Unlimited CompanyCo Cork, IrelandMakes the active ingredient Problems found, fixed voluntarilyOct 27, 2023 · 5 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
Janssen Pharmaceuticals, Inc.Titusville, NJ, United StatesTests it Problems found, fixed voluntarilySep 25, 2026 · 11 inspections

Product details

Generic drug
Darunavir: every company that makes it
Form
tablet, film coated, oral
Strength
75 mg
Approval
NDA NDA021976
On the market since
Jan 14, 2009
Package NDCs
59676-563-01
Official label
DailyMed (National Library of Medicine), updated Aug 29, 2025

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