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Darunavir and Cobicistat

Darunavir and cobicistat is a two-drug combination antiviral used to treat HIV-1 infection in adults and eligible pediatric patients, available as Prezcobix and Prezcobix Ped.

Brand names PrezcobixPrezcobix Ped
Drug class Cytochrome P450 3a Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 2 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 →

✓No current FDA shortage listed · checked Oct 6, 2026
Darunavir and Cobicistat at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Prezcobix pairs darunavir, an HIV protease inhibitor that blocks a protein the virus needs to copy itself, with cobicistat, a booster that slows the liver's breakdown of darunavir; on the market since about 2015, it is an established part of HIV treatment, valued for being hard for the virus to resist. Most people tolerate it well; diarrhea, nausea and headache are the usual complaints. The big thing is interactions, since the booster shifts levels of many common medicines and some, like simvastatin and St. John's wort, are off-limits. Expect liver and kidney blood tests, and stop it and seek care for a severe rash with fever or blisters.

Clinical pearls

  • Take it with a meal or snack every time, since food substantially increases how much darunavir your body absorbs.
  • Cobicistat predictably raises creatinine (a kidney blood test) without true kidney damage, so tell other prescribers who check it.
  • It is not recommended in pregnancy because darunavir levels fall in later trimesters, so plan a switch if you become pregnant.
  • Mention any sulfa (sulfonamide) allergy, since darunavir contains a sulfonamide component and needs closer watching.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2015
Companies listing it with the FDA2
FDA label last updatedFeb 1, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Darunavir and Cobicistat, written from its FDA label.

What Darunavir and Cobicistat is used for

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Darunavir and cobicistat is an antiviral combination used to treat HIV-1 infection. It is always given alongside other antiretroviral medicines.

  • Prezcobix (800 mg/150 mg tablet) treats HIV-1 in adults and pediatric patients weighing at least 40 kg — both new to treatment and previously treated — who have no specific darunavir resistance mutations
  • Prezcobix (675 mg/150 mg tablet) treats HIV-1 in pediatric patients weighing at least 25 kg to less than 40 kg with no darunavir resistance mutations
  • Prezcobix Ped (600 mg/90 mg tablet for oral suspension) treats HIV-1 in pediatric patients 3 years and older weighing at least 15 kg to less than 25 kg with no darunavir resistance mutations

How Darunavir and Cobicistat works

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Darunavir blocks an enzyme called HIV-1 protease — a tool the virus uses to assemble new copies of itself inside your body. Without this enzyme working properly, newly formed HIV particles cannot mature into infectious virus. Cobicistat is not an antiviral; it works by blocking a liver enzyme called CYP3A that would otherwise break down darunavir too rapidly. By inhibiting CYP3A, cobicistat keeps darunavir at effective levels in the bloodstream throughout the day.

Because this combination relies on blocking CYP3A, it also affects how dozens of other medications are processed in the body — which is why the drug interaction list for this medicine is unusually long and important.

Darunavir and Cobicistat dosage

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Prezcobix and Prezcobix Ped are both taken once daily by mouth, always with food. The right tablet strength depends on the patient's weight, and your prescriber will select the appropriate form.

  • Prezcobix film-coated tablets: taken whole; the 675 mg/150 mg tablet may be split for patients who have trouble swallowing
  • Prezcobix Ped: must be dispersed in water to form a suspension before taking — never swallowed whole or chewed
  • Always take with a full meal; skipping food significantly reduces how much darunavir your body absorbs
  • If you miss a dose, follow your prescriber's and pharmacist's instructions — do not double up without guidance

Dosing details from the FDA-approved label

From the Darunavir and Cobicistat 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.

  • Adults and pediatric patients weighing at least 40 kg
    • One 800 mg/150 mg tablet taken once daily with food
    • Given in conjunction with other antiretroviral agents; with tenofovir DF not recommended if estimated creatinine clearance is below 70 mL per minute
  • Pediatric patients weighing at least 25 kg to less than 40 kg
    • One 675 mg/150 mg tablet taken once daily with food
    • Assess ability to swallow tablets; if unable to swallow whole, the scored tablet may be split by hand into two pieces, each consumed immediately
  • Pediatric patients 3 years of age and older weighing at least 15 kg to less than 25 kg
    • One 600 mg/90 mg tablet for oral suspension (PREZCOBIX PED) taken once daily with food
    • Must be dispersed in drinking water and taken immediately with food; do not crush, chew or swallow the tablet
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Recommended dosage: Adults and pediatric patients weighing at least 40 kg: One 800 mg/150 mg tablet taken once daily with food. ( 2.1 , 2.2 ) Pediatric patients weighing at least 25 kg to less than 40 kg: One 675 mg/150 mg tablet taken once daily with food. ( 2.1 , 2.2 ) Pediatric patients 3 years of age and older weighing at least 15 kg to less than 25 kg: One 600 mg/90 mg tablet for oral suspension taken once daily with food. PREZCOBIX PED must be dispersed in drinking water and taken immediately with food. ( 2.2 , 2.3 ) Testing Prior to Initiation: HIV genotypic testing is recommended for antiretroviral treatment experienced patients. Assess estimated creatinine clearance in all patients prior to starting PREZCOBIX or PREZCOBIX PED. When used with tenofovir disoproxil fumarate (TDF): Assess urine glucose and urine protein at baseline and monitor creatinine clearance, urine glucose, and urine protein. Monitor serum phosphorus in patients with or at risk for renal impairment. ( 2.5 ) 2.1 Overview of Different Dosage Forms Two different dosage forms are available: PREZCOBIX Tablets: 800 mg/150 mg film-coated tablets for adults and pediatric patients weighing at least 40 kg. 675 mg/150 mg film-coated tablets for pediatric patients weighing at least 25 kg to less than 40 kg. PREZCOBIX PED Tablets for Oral Suspension: 600 mg/90 mg film-coated tablet for oral suspension for pediatric patients aged 3 years and older weighing at least 15 kg to less than 25 kg [see Dosage and Administration (2.2 , 2.3) ] . 2.2 Recommended Dosage in Adults and Pediatrics 3 Years of Age and Older Weighing at Least 15 kg The recommended dosages for adults and pediatric patients weighing at least 15 kg are shown in Table 1. The pediatric dose is based on weight. PREZCOBIX and PREZCOBIX PED are taken orally with food once daily in conjunction with other antiretroviral agents. Table 1: Recommended Dosages of PREZCOBIX and PREZCOBIX PED in Adults and Pediatric Patients Weighing at Least 15 kg, who are Treatment-Naïve or Treatment-Experienced Without DRV RAMs DRV-resistance-associated mutations (RAMs): V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Darunavir and Cobicistat side effects

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The most common side effects of darunavir, a component of these medicines, include:

Common side effects

  • Diarrhea
  • Nausea
  • Rash
  • Headache
  • Abdominal (stomach) pain
  • Vomiting

When to get medical help

  • Signs of liver problems: fatigue, loss of appetite, nausea, yellowing of skin or eyes (jaundice), dark urine, or upper stomach tenderness — call your doctor right away
  • Severe skin reactions: widespread rash especially with fever, blisters, mouth sores, or eye redness — stop the medicine and seek care immediately
  • Signs of kidney problems, especially if you're also taking tenofovir DF: changes in urination, swelling, or unusual fatigue
  • New or worsening diabetes symptoms: increased thirst, frequent urination, or confusion
  • Increased bleeding if you have hemophilia — contact your doctor
  • Signs of immune reconstitution syndrome (your immune system waking up and reacting to old infections): new fever, swollen glands, or breathing trouble after starting therapy

More serious reactions — including liver injury, severe skin reactions, kidney problems (especially with tenofovir DF), and new-onset diabetes — have been reported and require prompt medical attention if signs appear.

Darunavir and Cobicistat warnings and precautions

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  • Liver injury: Drug-induced hepatitis, including fatalities, has occurred — risk is highest in people with pre-existing hepatitis B or C. Watch for jaundice, dark urine, loss of appetite, or upper stomach pain and report these immediately.
  • Severe skin reactions: Rare but life-threatening skin conditions (Stevens-Johnson Syndrome, toxic epidermal necrolysis) have been reported. Stop the medicine and seek care at once if you develop a severe rash, blisters, or sores.
  • Kidney concerns with tenofovir DF: Acute kidney failure and Fanconi syndrome (a type of kidney damage affecting nutrient reabsorption) have been reported when cobicistat is used with tenofovir DF. Regular kidney monitoring is required.
  • Drug interactions: This medicine profoundly affects how many other drugs behave in the body — some combinations are life-threatening and absolutely contraindicated.
  • Creatinine test changes: Cobicistat causes a predictable rise in serum creatinine that does not reflect true kidney damage, but this can be confusing for other medical monitoring.
  • Not recommended in pregnancy: Drug levels drop dramatically during the second and third trimesters, risking treatment failure.

Darunavir and Cobicistat interactions

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This combination interacts with a large number of medications because it both inhibits and is processed by the CYP3A liver enzyme system. Key interactions include:

  • Rifampin, St. John's wort, carbamazepine, phenobarbital, phenytoin: Dramatically lower darunavir and cobicistat levels — contraindicated due to risk of treatment failure and resistance
  • Lovastatin, simvastatin: Levels rise dangerously — contraindicated due to risk of serious muscle damage
  • Lurasidone, pimozide, dronedarone, oral midazolam, triazolam, alfuzosin: Contraindicated due to risk of life-threatening side effects at elevated concentrations
  • Sildenafil (for pulmonary arterial hypertension): Contraindicated — concentration rises to dangerous levels
  • Elbasvir/grazoprevir (hepatitis C treatment): Contraindicated
  • Other antiretrovirals needing a booster (e.g., ritonavir, elvitegravir): Not recommended — can cause treatment failure
  • Efavirenz, etravirine, nevirapine: Not recommended — reduce effectiveness of this medicine
  • Blood thinners (warfarin, apixaban, rivaroxaban, dabigatran): Levels can be altered significantly; monitoring and possible dose adjustments needed
  • Antifungals, antibiotics (clarithromycin, erythromycin), antidepressants, cancer medicines: Levels of these drugs may be raised; monitoring required

Interactions listed in the FDA-approved label

From the Darunavir and Cobicistat prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Didanosine: The label lists no change in darunavir, cobicistat or didanosine concentrations. Administer didanosine one hour before or two hours after PREZCOBIX or PREZCOBIX PED (administered with food).
  • Efavirenz: Decreases cobicistat and darunavir concentrations, which may result in loss of therapeutic effect and development of resistance to darunavir. Co-administration is not recommended.
  • Etravirine: Decreases cobicistat; darunavir effect unknown; may result in loss of therapeutic effect and development of resistance to darunavir. Co-administration is not recommended.
  • Nevirapine: Decreases cobicistat; darunavir effect unknown; may result in loss of therapeutic effect and development of resistance to darunavir. Co-administration is not recommended.
  • Maraviroc: Increases maraviroc concentrations; maraviroc is a substrate of CYP3A. Patients should receive maraviroc 150 mg twice daily.
  • Alfuzosin: Increases alfuzosin; potential for serious and/or life-threatening reactions such as hypotension. Co-administration is contraindicated.
  • Clarithromycin, erythromycin, telithromycin: Increases darunavir, cobicistat and the antibacterial concentrations. Consider alternative antibiotics.
  • Rivaroxaban: Increases rivaroxaban and may lead to an increased bleeding risk. Co-administration is not recommended.
  • Carbamazepine, phenobarbital, phenytoin: Decreases darunavir and cobicistat, which may result in loss of therapeutic effect and development of resistance. Co-administration is contraindicated.
  • Rifampin: Decreases darunavir and cobicistat; potential for loss of therapeutic effect and development of resistance. Co-administration is contraindicated.
Read the label’s full interactions text

7 DRUG INTERACTIONS Co-administration of PREZCOBIX or PREZCOBIX PED with other drugs can alter the concentration of other drugs and other drugs may alter the concentrations of darunavir or cobicistat. Consult the full prescribing information prior to and during treatment for potential drug interactions. ( 4 , 5.6 , 7 , 12.3 ) 7.1 Potential for PREZCOBIX or PREZCOBIX PED to Affect Other Drugs Darunavir co-administered with cobicistat is an inhibitor of CYP3A and CYP2D6. Cobicistat inhibits the following transporters: P-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3. Therefore, co-administration of PREZCOBIX or PREZCOBIX PED with drugs that are primarily metabolized by CYP3A and/or CYP2D6 or are substrates of P-gp, BCRP, MATE1, OATP1B1 or OATP1B3 may result in increased plasma concentrations of such drugs, which could increase or prolong their therapeutic effect and can be associated with adverse events. Co-administration of PREZCOBIX or PREZCOBIX PED 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 2 ). 7.2 Potential for Other Drugs to Affect PREZCOBIX or PREZCOBIX PED Darunavir is metabolized by CYP3A. Cobicistat is metabolized by CYP3A, and to a minor extent, by CYP2D6. Co-administration of PREZCOBIX or PREZCOBIX PED and drugs that induce CYP3A activity are expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations of darunavir and cobicistat which may lead to loss of therapeutic effect and development of resistance. Co-administration of PREZCOBIX or PREZCOBIX PED and other drugs that inhibit CYP3A may result in increased plasma concentrations of darunavir and cobicistat (see Table 2 ).

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.

🌿173 supplements and herbs with documented Darunavir and Cobicistat interactions, ranked by severity Check Darunavir and Cobicistat against a supplement or herb →

Before taking Darunavir and Cobicistat

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  • Tell your prescriber about every medicine, vitamin, supplement, and herbal product you take — the interaction list for this combination is exceptionally broad
  • This medicine is not recommended during pregnancy; drug levels fall too low in the second and third trimesters to reliably suppress HIV
  • Do not breastfeed while taking this medicine
  • Not approved for children younger than 3 years old or weighing less than 15 kg
  • Tell your doctor if you have hepatitis B or C, cirrhosis, or other liver disease — you need closer monitoring and are at higher risk for serious liver reactions
  • Tell your doctor about any sulfonamide (sulfa drug) allergy — darunavir contains a sulfonamide component
  • Tell your doctor if you have hemophilia — HIV protease inhibitors have been associated with increased bleeding
  • Kidney function should be assessed before starting; if you are also taking tenofovir DF, ongoing kidney monitoring is required
  • Prezcobix is not recommended in patients with severe liver impairment

Darunavir and Cobicistat overdose

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There is limited human experience with overdose of Prezcobix or Prezcobix Ped. There is no specific antidote. If an overdose is suspected, seek emergency medical care — treatment focuses on supportive measures and monitoring vital signs. Because darunavir and cobicistat are highly bound to proteins in the blood, dialysis is not expected to remove meaningful amounts of the drug.

What Darunavir and Cobicistat does in the body

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Cobicistat causes a predictable, modest rise in measured serum creatinine by blocking the kidneys' tubular secretion of creatinine — but it does not actually reduce the true filtration rate of the kidneys (glomerular filtration rate). This means routine creatinine-based kidney estimates will look worse than they really are while on this medicine. Cobicistat did not significantly prolong the QT interval (a measure of heart electrical activity) at therapeutic doses, though it did cause a modest prolongation of the PR interval (another electrical measurement) at higher doses.

How your body processes Darunavir and Cobicistat

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Darunavir reaches peak blood concentration approximately 4 to 4.5 hours after taking a Prezcobix or Prezcobix Ped tablet, and cobicistat peaks at about 4 to 5 hours. Food has a significant effect: taking Prezcobix with a high-fat meal increases darunavir exposure by approximately 70% compared to fasting, so taking it with food is essential. Darunavir is extensively metabolized by the CYP3A enzyme in the liver; cobicistat inhibits this enzyme, which is precisely how it boosts darunavir levels. Darunavir is approximately 95% bound to plasma proteins, and cobicistat is 97–98% protein-bound. After metabolism, darunavir is eliminated primarily in the feces.

How to store Darunavir and Cobicistat

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of PREZCOBIX tablets: Store at 20 °C to 25 °C (between 68 °F to 77 °F); with excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) . of PREZCOBIX PED tablets for oral suspension: Store in the original container in order to protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

173

Supplements & herbs that interact with Darunavir and Cobicistat

173 supplements and herbal products have documented interactions with Darunavir and Cobicistat in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 131
  • Minor · 36
ACTIVATED CHARCOAL Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major WINE Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate +165 more
Every supplement checked against Darunavir and Cobicistat — ranked by severity The full interaction hub: 6 major · 131 moderate · 36 minor · every one linked to its full report. Check Darunavir and Cobicistat against your exact supplements

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 and Cobicistat: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Darunavir and Cobicistat — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does this medicine do for HIV?

▾
Prezcobix and Prezcobix Ped work by blocking a key enzyme HIV needs to make new copies of itself. Darunavir is the active antiviral, and cobicistat is added to keep darunavir at effective levels in your bloodstream throughout the day. Together with your other HIV medicines, this combination helps lower the amount of virus in your body and keeps your immune system stronger. It won't cure HIV, but taken consistently it can help control the infection.

Do I really have to take this with food every time?

▾
Yes — this is one of the most important rules with Prezcobix and Prezcobix Ped. Taking darunavir without food can cut how much of it your body absorbs by nearly half. It doesn't have to be a huge meal, but you do need to eat something every time you take your dose. Make taking it with a meal part of your daily routine — breakfast, lunch, or dinner works fine.

What side effects should I expect, and which ones should make me call my doctor?

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The most common side effects are digestive ones — diarrhea, nausea, stomach pain, and vomiting — plus headache and mild rash. A mild rash in the first few weeks is fairly common and often goes away on its own. However, call your doctor right away if you get a severe rash with fever, blisters, or sores in your mouth or eyes — that could be a serious skin reaction. Also contact your doctor quickly if you notice yellowing of your skin or eyes, dark urine, or unusual tiredness, which could point to liver problems.

I take a lot of other medications. Should I be worried about interactions?

▾
Yes, and this is really important — this medicine interacts with a very wide range of drugs, including some that are completely off-limits to take with it. Things like certain cholesterol medicines (lovastatin, simvastatin), the herbal supplement St. John's wort, some seizure medicines, and several heart or psychiatric medications can either become dangerous at higher levels or cause this medicine to stop working. Before you start, make sure your doctor and pharmacist know every single medicine, supplement, and herbal product you take so they can check for problems.

Can I take this medicine if I'm pregnant or trying to get pregnant?

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Prezcobix and Prezcobix Ped are not recommended during pregnancy. Studies showed that darunavir and cobicistat blood levels drop significantly during the second and third trimesters, which could allow HIV to become detectable again — a serious concern. If you're already pregnant, your doctor should switch you to a different HIV regimen. If you're of childbearing age and taking this medicine, use effective contraception and talk to your doctor about your options. There is also a pregnancy registry you can join so your outcome can be tracked — your doctor can give you the details.

My blood test shows my creatinine went up since starting this — should I be worried?

▾
Most of the time, no — this is actually a known and expected effect of cobicistat, one of the drugs in this combination. Cobicistat blocks a step in how the kidneys handle creatinine, making the test look worse than reality. Your actual kidney filtering function is usually unchanged. That said, your doctor should still track it, and if the rise is larger than expected or you develop other symptoms, they'll investigate further. Always mention any changes in urination or swelling to your care team.

Is Darunavir and Cobicistat available over the counter?

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No. Darunavir and Cobicistat is a prescription medicine: every Darunavir and Cobicistat product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Darunavir and Cobicistat first available?

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The earliest FDA record we hold for Darunavir and Cobicistat is from 2015: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Darunavir and Cobicistat was first used.

Who makes Darunavir and Cobicistat?

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2 companies currently list Darunavir and Cobicistat products in the FDA's NDC Directory, including Janssen Products, LP, A-S Medication Solutions. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Darunavir and Cobicistat on HelloPharmacist

📊Darunavir and Cobicistat supplement interactions173 checked — ranked by severity 🌿Drug & Supplement CheckerDarunavir and Cobicistat vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Darunavir and Cobicistat NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Darunavir and Cobicistat Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Darunavir and Cobicistat forms and strengths (how it comes)

Darunavir and Cobicistat is available in 1 form. 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Darunavir and Cobicistat inactive ingredients by manufacturer.

Tablet

By mouth
Brands Prezcobix Prezcobix Ped
How this form is used
What it may be used for
  • Prezcobix tablets (800 mg/150 mg) are used to treat HIV-1 infection in adults and pediatric patients weighing at least 40 kg, in combination with other antiretroviral agents
  • Prezcobix tablets (675 mg/150 mg) are used to treat HIV-1 infection in pediatric patients weighing at least 25 kg to less than 40 kg, in combination with other antiretroviral agents
  • Prezcobix Ped tablets for oral suspension (600 mg/90 mg) are used to treat HIV-1 infection in pediatric patients 3 years and older weighing at least 15 kg to less than 25 kg, in combination with other antiretroviral agents
Important instructions
  • Prezcobix tablets are taken by mouth once daily with food; the 675 mg/150 mg tablet may be split if the child cannot swallow it whole, and each piece should be taken immediately after splitting
  • Prezcobix Ped tablets for oral suspension must be dispersed in 30 mL of non-carbonated room-temperature drinking water, stirred well, and taken immediately — do not crush, chew, or swallow the tablet whole
  • Prezcobix Ped oral suspension may be further diluted with a small amount of water, orange juice, applesauce, or yogurt to aid administration; rinse the cup with additional water and drink completely to ensure the full dose is taken
  • Both Prezcobix and Prezcobix Ped are taken once daily and must always be taken with food, as food significantly increases darunavir absorption
Available strengths 6 strengths
90 mg / 600 mg 150 mg / 675 mg 150 mg / 800 mg 600 mg / 90 mg 675 mg / 150 mg 800 mg / 150 mg
10 FDA-listed product records ⓘ

Darunavir and Cobicistat on the U.S. market: products, makers and brands

How Darunavir and Cobicistat 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.

2 companies list 4 Darunavir and Cobicistat product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2015. Brand names on the directory include Prezcobix, Prezcobix Ped; the rest are generics.

1
Dose forms ⓘ
2
Labelers (makers, repackagers, distributors)
2
Brand names
4
FDA-listed product records ⓘ
2015
Earliest FDA record ⓘ
Janssen Products, LP75%
A-S Medication Solutions25%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Darunavir and Cobicistat is used (Medicaid data)

A general measure of how commonly Darunavir and Cobicistat 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 and Cobicistat 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.

32,250
Medicaid prescriptions filled (Q1–Q4 2025)
$83.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Darunavir and Cobicistat prescribed? Of the 1,601 medications we measure, Darunavir and Cobicistat ranks #720 by Medicaid prescriptions — more than 55% of them.

Where Darunavir and Cobicistat ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #720 of 1,601
#715 Benralizumab Injection 33,442 Rx #716 Ciclesonide Oral Inhal... 33,286 Rx #717 Indapamide 32,997 Rx #718 Dicloxacillin 32,884 Rx #719 Ropivacaine 32,308 Rx #720 Darunavir and Cobicist... 32,250 Rx #721 Certolizumab Injection 32,049 Rx #722 Penicillin G Benzathin... 31,924 Rx #723 Filgrastim Injection 31,849 Rx #724 Guselkumab Injection 31,774 Rx #725 Loxapine 31,747 Rx

Utilization by Darunavir and Cobicistat 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.

cobicistat 150 MG / darunavir 800 MG Oral Tablet

32,250 Medicaid prescriptions (Q1–Q4 2025) 100% of Darunavir and Cobicistat prescriptions shown $83.9M gross reimbursement (before rebates) ≈ $2,601 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1600704

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 Cobicistat, 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 1 of 3 listed Darunavir and Cobicistat NDCs with Medicaid activity.

Compare Darunavir and Cobicistat products

A representative set of FDA-listed product records for Darunavir and Cobicistat — 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
💊Tablet
DARUNAVIR ETHANOLATE 800 mg/1; COBICISTAT 150 mg Oral A-S Medication Solutions NDA View NDC →
DARUNAVIR ETHANOLATE 90 mg/1; COBICISTAT 600 mg Oral Janssen Products, LP NDA View NDC →
DARUNAVIR ETHANOLATE 150 mg/1; COBICISTAT 675 mg Oral Janssen Products, LP NDA View NDC →
DARUNAVIR ETHANOLATE 150 mg/1; COBICISTAT 800 mg Oral Janssen Products, LP NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Darunavir and Cobicistat NDCs →

Darunavir and Cobicistat 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 and Cobicistat recalls since July 2021.

✅No Darunavir and Cobicistat recalls on record since July 2021

Source: 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 exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Darunavir and Cobicistat RxCUI 1598380 2 dose forms · 3 strengths

Look up RxCUI 1598380 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.

💵 What Darunavir and Cobicistat 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.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 150; 800 mg/1; mg $79.99 per tablet NDC details & price history
Tablet, Film Coated · Oral DARUNAVIR ETHANOLATE 150 mg/1; COBICISTAT 800 mg $79.99 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full 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 and Cobicistat brand names

Darunavir and Cobicistat is sold under 2 brand names in the FDA directory — Prezcobix, Prezcobix Ped. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Prezcobix Prezcobix Ped

Who makes Darunavir and Cobicistat: manufacturers and labelers

2 companies list Darunavir and Cobicistat products with the FDA. By number of product records, the largest are Janssen Products, LP, A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Janssen Products, LP 3 A-S Medication Solutions 1

Darunavir and Cobicistat drug class (RxNorm)

Darunavir and Cobicistat belongs to the Cytochrome P450 3A Inhibitor class.

Pharmacologic class Cytochrome P450 3A Inhibitor
Drug family (ATC) Other therapeutic products
How it works Cytochrome P450 2D6 Inhibitors, P-Glycoprotein Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Organic Anion Transporting Polypeptide 1B3 Inhibitors

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 and Cobicistat 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 1, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Darunavir and Cobicistat.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Darunavir and Cobicistat after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
4
Companies listing them (makers, repackagers, distributors)
2
FDA labeler codes behind them ⓘ
2
Linked representative label ⓘ
Janssen Products LP
Linked label effective
Feb 1, 2026
Composite sections available
23
Linked SPL Set ID
9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f
Linked SPL Document ID
9d92f536-2a35-4d1d-baca-8d87e8b8dcaf
Open the linked representative label on DailyMed ↗

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 →