Quick answers
- What is Darunavir used for?
- The FDA-approved label (Prezista, Janssen Products LP, August 29, 2025) says: “PREZISTA, co-administered with ritonavir (PREZISTA/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 […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Darunavir have a boxed warning?
- The label we quote has no boxed warning, but 1 of 15 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Darunavir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Darunavir been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Darunavir?
- 14 companies list prescription products of Darunavir in the FDA NDC Directory, including Janssen Products, LP, Camber Pharmaceuticals, Inc. and Viona Pharmaceuticals Inc.
What Darunavir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PREZISTA, co-administered with ritonavir (PREZISTA/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 […]. …
— FDA label: Prezista, Janssen Products LP, effective August 29, 2025. Read the full label on DailyMed →
The FDA has 15 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
1 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Suspension |
|---|---|
| Route | Oral |
| Prescription products | 32 in the FDA NDC Directory |
| Brand names | Prezista |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| darunavir 600 mg tablet, film coated | Generic | $1.12 per tablet |
| darunavir 800 mg tablet, film coated | Generic | $2.18 per tablet |
| darunavir dihydrate 600 mg tablet | Generic | $1.12 per tablet |
| darunavir dihydrate 800 mg tablet | Generic | $2.18 per tablet |
| darunavir ethanolate 600 mg tablet, film coated | Generic | $1.12 per tablet |
| darunavir ethanolate 600 mg tablet, film coated | Brand: Prezista | $34.86 per tablet |
| darunavir ethanolate 800 mg tablet, film coated | Generic | $2.18 per tablet |
| darunavir ethanolate 800 mg tablet, film coated | Brand: Prezista | $70.08 per tablet |
| darunavir hydrate 600 mg tablet | Generic | $1.12 per tablet |
| darunavir hydrate 800 mg tablet | Generic | $2.18 per tablet |
| darunavir propylene glycolate 600 mg tablet, film coated | Generic | $1.12 per tablet |
| darunavir propylene glycolate 800 mg tablet, film coated | Generic | $2.18 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Janssen Products, LP5 products
- Camber Pharmaceuticals, Inc.4 products
- Viona Pharmaceuticals Inc2 products
- Amneal Pharmaceuticals NY LLC2 products
- Bryant Ranch Prepack2 products
- Dr.Reddys Laboratories Inc2 products
- Zydus Lifesciences Limited2 products
- Novadoz Pharmaceuticals LLC2 products
- Lupin Pharmaceuticals, Inc.2 products
- Exelan Pharmaceuticals Inc.2 products
- Cipla USA Inc.2 products
- American Health Packaging2 products
- Aurobindo Pharma Limited2 products
- NuCare Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021976 PREZISTA | Janssen Prods | June 23, 2006 | 48, latest March 31, 2023 2023: Labeling · 2022: Labeling · 2022: Labeling |
| NDA202895 PREZISTA | Janssen Prods | December 16, 2011 | 27, latest March 31, 2023 2023: Labeling · 2022: Labeling · 2022: Labeling |
Generic approvals (9)
- ANDA202073Lupin · September 29, 2022
- ANDA202083Hetero Labs Ltd III · September 14, 2023
- ANDA206288Cipla · November 28, 2023
- ANDA210677Aurobindo Pharma Ltd · November 28, 2023
- ANDA211578DR Reddys · November 28, 2023
- ANDA215389Msn · November 28, 2023
- ANDA212493Amneal · December 8, 2023
- ANDA214085Zydus Lifesciences · December 13, 2023
- ANDA216168Annora Pharma · January 21, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prezista, Janssen Products LP, effective August 29, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →