FDA label
What is darunavir used for?
The FDA-approved uses of darunavir, 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: “Darunavir tablets, co-administered with ritonavir (darunavir tablets/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older.”
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Darunavir, tablet, film coated
Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA216168). Cross-references to other label sections are left out.
Darunavir tablets, co-administered with ritonavir (darunavir tablets/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older.
Source: DailyMed label, set id 49606d5e-f45f-45eb-9ab8-15aa6a233875, version 2, effective March 19, 2025. NDC 31722-088, one of 15 listings for this product.
Darunavir, tablet
Indications and Usage, quoted from the label by American Health Packaging (ANDA206288). Cross-references to other label sections are left out.
Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations and Clinical Studies ].
Source: DailyMed label, set id 632293b0-d220-444e-8a5b-2ee8c225b66d, version 3, effective September 15, 2026. NDC 60687-808, one of 3 listings for this product.
Questions
What is darunavir used for?
The FDA label says: “Darunavir tablets, co-administered with ritonavir (darunavir tablets/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older.”
What drug class is darunavir?
FDA lists darunavir in the 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.