Darunavir
Darunavir is an HIV-1 protease inhibitor used, together with ritonavir and other HIV medicines, to treat HIV-1 infection in adults and children 3 years and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 16 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Darunavir (Prezista) treats HIV-1 by blocking protease, the enzyme the virus needs to build mature copies of itself, and is always taken with ritonavir (which boosts its levels) and other HIV medicines; on the market since about 2006 and available as a generic, it is usually the first-choice protease inhibitor when one is needed. Most people tolerate it well, and diarrhea, nausea and a mild rash that often fades on its own are what people notice. Get care right away for a severe rash, especially with fever, blisters or mouth sores, or for signs of liver trouble like yellow eyes or dark urine.
Clinical pearls
- Take each dose with a meal, never on an empty stomach, because food is what lets enough darunavir get absorbed.
- Never skip doses or leave out ritonavir, since low darunavir levels let HIV work around it and can limit future options.
- Simvastatin, lovastatin, rifampin and St. John’s wort are off-limits, so clear every new prescription, over-the-counter or herbal product first.
- It can make birth control pills less reliable, so add a condom or switch to a non-hormonal method.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
BOXED WARNING
Read the full warning on DailyMed →Patient information guide A plain-language walkthrough of Darunavir, written from its FDA label.
What Darunavir is used for
▾
Darunavir treats HIV-1 infection when used with ritonavir and other HIV medicines.
- HIV-1 infection in adults and children 3 years of age and older (Prezista tablets and oral suspension, and darunavir tablets).
How Darunavir works
▾
Darunavir is an HIV-1 protease inhibitor. It blocks the HIV enzyme that cuts virus proteins (Gag-Pol polyproteins) into working pieces. Without that step, infected cells can't produce mature virus particles.
Ritonavir slows how fast the body breaks darunavir down, so darunavir reaches effective levels.
Darunavir dosage
▾
Darunavir is taken by mouth with ritonavir and with food. Your schedule depends on your situation.
- Adults who haven't had HIV treatment, or who have no resistance to darunavir, usually take it once daily.
- Adults with certain resistance, and pregnant patients, usually take it twice daily.
- Children's doses are based on body weight and don't exceed the adult dose.
Follow your prescriber and label. Skipping ritonavir or food can make darunavir work less well.
Dosing details from the FDA-approved label
From the Darunavir prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Treatment-naïve adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions
- 800 mg (one 800 mg tablet or 8 mL of the oral suspension) taken with ritonavir 100 mg once daily and with food
- An 8 mL dose is taken as two 4 mL administrations with the included oral dosing syringe
- Treatment-experienced adult patients with at least one darunavir resistance associated substitution, or with no baseline resistance information
- 600 mg (one 600 mg tablet or 6 mL oral suspension) taken with ritonavir 100 mg twice daily and with food
- Baseline genotypic testing is recommended for dose selection; when not feasible, 600 mg with ritonavir 100 mg twice daily is recommended
- Pregnant patients
- 600 mg taken with ritonavir 100 mg twice daily with food
- 800 mg with ritonavir 100 mg once daily only for certain patients already stable on it before pregnancy and virologically suppressed (HIV-1 RNA less than 50 copies per mL)
- Pediatric patients weighing at least 10 kg but less than 15 kg, treatment-naïve or treatment-experienced with no darunavir resistance associated substitutions
- PREZISTA 35 mg/kg once daily with ritonavir 7 mg/kg once daily, with food
- Maximum: Should not exceed the recommended adult dose
- Dose is based on body weight; oral suspension used in this weight band
- Pediatric patients (3 to less than 18 years of age and weighing at least 10 kg)
- Dose of PREZISTA and ritonavir is based on body weight (see Tables 2, 3, 4 and 5)
- Taken with ritonavir and with food
- Maximum: Should not exceed the recommended adult dose
- Children weighing 15 kg or more should be assessed for ability to swallow tablets; if unable, consider oral suspension
- Severe hepatic impairment
- Not recommended
- Monitor serum liver chemistry before and during therapy
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Testing: In treatment-experienced patients, treatment history genotypic and/or phenotypic testing is recommended prior to initiation of therapy with darunavir/ritonavir to assess drug susceptibility of the HIV-1 virus ( 2.1 , 12.4 ) Monitor serum liver chemistry tests before and during therapy with darunavir/ritonavir. ( 2.1 , 2.2 , 5.2 ) Treatment-naïve adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions: 800 mg (one 800 mg tablet) taken with ritonavir 100 mg once daily and with food. ( 2.3 ) Treatment-experienced adult patients with at least one darunavir resistance associated substitution: 600 mg (one 600 mg tablet) taken with ritonavir 100 mg twice daily and with food. ( 2.3 ) Pregnant patients: 600 mg (one 600 mg tablet) taken with ritonavir 100 mg twice daily and with food. ( 2.4 ) Pediatric patients (3 to less than 18 years of age and weighing at least 10 kg): dosage of darunavir tablets and ritonavir is based on body weight and should not exceed the adult dose. Darunavir tablets should be taken with ritonavir and with food. ( 2.5 ) Darunavir/ritonavir is not recommended for use in patients with severe hepatic impairment. ( 2.6 ) 2.1 Testing Prior to Initiation of darunavir/ritonavir In treatment-experienced patients, treatment history, genotypic and/or phenotypic testing is recommended to assess drug susceptibility of the HIV-1 virus [see Microbiology (12.4) ] . Refer to Dosage and Administration (2.3) , (2.4) and ( 2.5 ) for dosing recommendations. Appropriate laboratory testing such as serum liver biochemistries should be conducted prior to initiating therapy with darunavir/ritonavir [see Warnings and Precautions (5.2) ]. 2.2 Monitoring During Treatment with darunavir/ritonavir Patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases should be monitored for elevation in serum liver biochemistries, especially during the first several months of darunavir/ritonavir treatment [see Warnings and Precautions (5.2) ]. 2.3 Recommended Dosage in Adult Patients Darunavir tablets must be co-administered with ritonavir to exert its therapeutic effect.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Darunavir side effects
▾
Most side effects are mild to moderate. Common ones include:
Common side effects
- Diarrhea
- Nausea
- Rash
- Headache
- Abdominal (belly) pain
- Vomiting
When to get medical help
- Call your doctor right away if you have a severe rash, or a rash with fever, blisters, mouth sores, red eyes, or muscle or joint aches. Severe skin reactions can happen.
- Call your doctor if you have signs of liver problems: unusual tiredness, loss of appetite, nausea, yellow skin or eyes, dark urine, or liver tenderness.
- Tell your doctor about increased thirst, urination, or high blood sugar. New or worsening diabetes has been reported with this type of medicine.
- Report new symptoms of inflammation or infection soon after starting HIV treatment. This can be immune reconstitution syndrome.
- If you have hemophilia, report any unusual bleeding or bruising.
Darunavir warnings and precautions
▾
- Liver problems: hepatitis and liver injury, including some deaths, have been reported. Liver tests are done before and during treatment.
- Severe skin reactions: including Stevens-Johnson syndrome. Stop and seek care if a severe rash develops.
- Sulfa allergy: use with caution.
- Blood sugar: new or worse diabetes and high blood sugar can occur.
- Body fat changes and immune reconstitution syndrome can occur.
- Hemophilia: bleeding may increase.
- Under 3 years of age: not recommended.
Darunavir interactions
▾
Darunavir with ritonavir changes levels of many drugs.
- Contraindicated drugs such as simvastatin, lovastatin, rifampin, St. John’s wort, pimozide, and oral midazolam or triazolam can cause serious harm or make darunavir less effective.
- Birth control pills may work less well, so use a non-hormonal or barrier method.
- Other HIV protease inhibitors like lopinavir/ritonavir and saquinavir are not recommended with it.
- Maraviroc needs a dose adjustment, and didanosine needs different timing.
- Colchicine is contraindicated in kidney or liver impairment.
Interactions listed in the FDA-approved label
From the Darunavir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Didanosine: Darunavir concentration is unchanged and didanosine concentration is unchanged. Didanosine should be administered one hour before or two hours after darunavir/ritonavir (which are administered with food).
- Indinavir: Darunavir concentration increases and indinavir concentration increases. The appropriate dose of indinavir in combination with darunavir/ritonavir has not been established.
- Lopinavir/ritonavir: Darunavir concentration decreases and lopinavir concentration is unchanged. Not recommended to co-administer lopinavir/ritonavir and darunavir, with or without ritonavir; appropriate doses have not been established.
- Saquinavir: Darunavir concentration decreases and saquinavir concentration is unchanged. Not recommended to co-administer saquinavir and darunavir, with or without ritonavir; appropriate doses have not been established.
- Other HIV protease inhibitors, except atazanavir: Co-administration with darunavir/ritonavir has not been studied. Co-administration is not recommended.
- Maraviroc: Maraviroc concentration increases. When used with darunavir/ritonavir, the dose of maraviroc should be 150 mg twice daily.
- Alfuzosin: Alfuzosin concentration increases, with potential for serious and/or life-threatening reactions such as hypotension. Co-administration is contraindicated.
- Clarithromycin: Darunavir concentration is unchanged and clarithromycin concentration increases. No dose adjustment required with normal renal function; in renal impairment, for CLcr of 30-60 mL/min reduce the clarithromycin dose by 50%.
- Drugs primarily metabolized by CYP3A and CYP2D6 or transported by P-gp: Darunavir with ritonavir inhibits CYP3A, CYP2D6 and P-gp, which may increase plasma concentrations of such drugs, increasing or prolonging their effect and adverse events. Consider potential interactions before and during therapy; consult the label of each co-administered drug.
- Drugs that induce CYP3A activity, or inhibit CYP3A or P-gp: CYP3A inducers are expected to lower darunavir and ritonavir plasma concentrations; CYP3A or P-gp inhibitors may increase them.
Read the label’s full interactions text
7 DRUG INTERACTIONS Co-administration of darunavir/ritonavir with other drugs can alter the concentrations of other drugs and other drugs may alter the concentrations of darunavir. The potential drug-drug interactions must be considered prior to and during therapy. ( 4 , 5.5 , 7 , 12.3 ) 7.1 Potential for darunavir/ritonavir to Affect Other Drugs Darunavir co-administered with ritonavir is an inhibitor of CYP3A, CYP2D6, and P-gp. Co-administration of darunavir and ritonavir with drugs that are primarily metabolized by CYP3A and CYP2D6 or are transported by P-gp may result in increased plasma concentrations of such drugs, which could increase or prolong their therapeutic effect and adverse events. Darunavir co-administered with ritonavir with drugs that have active metabolite(s) formed by CYP3A may result in reduced plasma concentrations of these active metabolite(s), potentially leading to loss of their therapeutic effect (see Table 10). 7.2 Potential for Other Drugs to Affect Darunavir Darunavir and ritonavir are metabolized by CYP3A. In vitro data indicate that darunavir may be a P-gp substrate. Drugs that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of darunavir and ritonavir. Co-administration of darunavir and ritonavir and other drugs that inhibit CYP3A, or P-gp may decrease the clearance of darunavir and ritonavir and may result in increased plasma concentrations of darunavir and ritonavir (see Table 10). 7.3 Established and Other Potentially Significant Drug Interactions Table 10 provides dosing recommendations as a result of drug interactions with darunavir/ritonavir. These recommendations are based on either drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of efficacy.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Darunavir
▾
- Liver disease, including hepatitis B or C: needs monitoring. Not recommended in severe liver impairment.
- Sulfa allergy.
- Diabetes or hemophilia.
- Pregnancy: drug levels fall during pregnancy, and twice daily dosing is generally recommended.
- Breastfeeding: people with HIV are advised not to breastfeed.
- Children under 3 years of age should not take it.
Darunavir overdose
▾
Experience with overdose is limited, and there is no specific antidote. Treatment is supportive care, with monitoring of vital signs and clinical status. Dialysis is unlikely to help. Call poison control or seek emergency care.
What Darunavir does in the body
▾
In a study of 40 healthy people, darunavir with ritonavir at 1.33 times the maximum recommended dose did not affect the QT/QTc interval, a measure of heart rhythm timing.
How your body processes Darunavir
▾
Darunavir with ritonavir is absorbed in roughly 2.5 to 4 hours. Ritonavir raises darunavir exposure about 14-fold, and bioavailability rises from 37% to 82%. Taking tablets with food raises levels by about 40%.
The liver breaks darunavir down, mainly through CYP3A. Most of it leaves in the stool, with some in urine. The half-life is about 15 hours with ritonavir.
How to store Darunavir
▾
PREZISTA Oral Suspension Store at 25°C (77°F); with excursions permitted to 15°–30°C (59°–86°F). Do not refrigerate or freeze. Store in the original container.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Darunavir
145 supplements and herbal products have documented interactions with Darunavir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 102
- Minor · 40
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Darunavir: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Darunavir — the kind of thing our pharmacy team would talk through with you at the counter.
What is darunavir for?
▾
Why do I have to take it with ritonavir and food?
▾
What side effects should I expect?
▾
What should I call my doctor about right away?
▾
Can I take my other medicines with it?
▾
Does it affect birth control or pregnancy?
▾
Is Darunavir available over the counter?
▾
When was Darunavir first available?
▾
Who makes Darunavir?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Darunavir on HelloPharmacist
Darunavir forms and strengths (how it comes)
Darunavir is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Darunavir tablets and Prezista are used with ritonavir and other HIV medicines to treat HIV-1 infection in adults and children 3 years and older.
- Darunavir tablets and Prezista are taken by mouth with ritonavir and with food.
- Prezista and darunavir tablet regimens may be once or twice daily depending on treatment history and pregnancy status.
Oral suspension
How this form is used
- Prezista is used with ritonavir and other HIV medicines to treat HIV-1 infection in adults and children 3 years and older.
- Prezista is taken by mouth with ritonavir and with food.
- For children, Prezista and ritonavir dosing is based on body weight and should not exceed the adult dose.
Darunavir on the U.S. market: products, makers and brands
How Darunavir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
14 companies list 32 Darunavir product records with the FDA, mostly as tablet, oral suspension; the earliest marketing or approval year on record is 2006. Brand names on the directory include Prezista; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (13) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Darunavir is used (Medicaid data)
A general measure of how commonly Darunavir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Darunavir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Darunavir prescribed? Of the 1,601 medications we measure, Darunavir ranks #921 by Medicaid prescriptions — more than 42% of them.
Utilization by Darunavir product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
darunavir 800 MG Oral Tablet Most dispensed
Summed across the 9 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1359269
darunavir 600 MG Oral Tablet
Summed across the 6 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 670026
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Darunavir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 15 of 43 listed Darunavir NDCs with Medicaid activity.
Compare Darunavir products
A representative set of FDA-listed product records for Darunavir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral suspension | ||||
| 100 mg/mL | Oral | Janssen Products LP | NDA | View NDC → |
| 💊Tablet | ||||
| 600 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 800 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 600 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 800 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 600 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 800 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 800 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 400 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 600 mg | Oral | Camber Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 800 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 600 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 800 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 600 mg | Oral | Dr.Reddys Laboratories Inc | ANDA | View NDC → |
| 800 mg | Oral | Dr.Reddys Laboratories Inc | ANDA | View NDC → |
| 600 mg | Oral | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 800 mg | Oral | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 75 mg | Oral | Janssen Products LP | NDA | View NDC → |
| 150 mg | Oral | Janssen Products LP | NDA | View NDC → |
| 600 mg | Oral | Janssen Products LP | NDA | View NDC → |
| 800 mg | Oral | Janssen Products LP | NDA | View NDC → |
| 600 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 800 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 600 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 800 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 800 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 600 mg | Oral | Viona Pharmaceuticals Inc | ANDA | View NDC → |
| 800 mg | Oral | Viona Pharmaceuticals Inc | ANDA | View NDC → |
| 600 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 800 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
Showing 32 of 32 products — FDA National Drug Code Directory. See every product, package size and price: browse all 32 Darunavir NDCs →
Darunavir side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Darunavir — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Darunavir in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Darunavir FDA approval history
How Darunavir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Darunavir recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Darunavir recalls since July 2021.
✅No Darunavir recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 460132 2 dose forms · 7 strengths
-
Dose form (SCDF) Oral Suspension RxCUI 1236627In current FDA listingsClinical drug / strength (SCD) 100 MG/MLRxCUI 1236628 -
Dose form (SCDF) Oral Tablet RxCUI 643073In current FDA listings
Look up RxCUI 460132 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Darunavir supply and shortage status
Whether Darunavir is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Darunavir costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 800 mg | $2.38 per tablet | NDC details & price history |
| Tablet · Oral | 800 mg | $2.38 per tablet | NDC details & price history |
| Tablet · Oral | 600 mg | $1.16 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Darunavir brand names
Darunavir is sold under one brand name in the FDA directory — Prezista. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Darunavir: manufacturers and labelers
14 companies list Darunavir products with the FDA. By number of product records, the largest are Janssen Products LP, Camber Pharmaceuticals, Inc., American Health Packaging. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Darunavir drug class (RxNorm)
Darunavir belongs to the Protease Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Darunavir page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Janssen Products LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →