FDA label
What is Prezcobix used for?
Prezcobix contains darunavir ethanolate and cobicistat. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).”
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Prezcobix, tablet, film coated
Indications and Usage, quoted from the label by Janssen Products, LP (NDA205395). Cross-references to other label sections are left out.
PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
Source: DailyMed label, set id 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f, version 29, effective February 1, 2026. NDC 59676-575, one of 3 listings for this product.
Questions
What is Prezcobix used for?
The FDA label says: “PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).”
What drug class is Prezcobix?
FDA lists darunavir ethanolate and cobicistat in the Cytochrome P450 3A Inhibitor and Protease Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Prezcobix
- Is Prezcobix a controlled substance?Federal schedule
- Generic for PrezcobixFDA Orange Book
- Generic for Prezcobix PedFDA Orange Book
- Cytochrome P450 3A Inhibitors listFDA drug class
- Protease Inhibitors listFDA drug class
- Prezcobix Medicare Part D coverageBy plan and state
- NDC 50090-1723Prezcobix NDC record
- NDC 59676-575Prezcobix NDC record
- NDC 59676-578Prezcobix NDC record