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Raltegravir

Raltegravir is an HIV-1 integrase strand transfer inhibitor (an antiviral) used with other HIV medicines to treat HIV-1 infection in adults and in children weighing at least 2 kg.

Brand names IsentressIsentress HD
Drug class Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Rx Forms 3
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 6 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
Raltegravir 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

Raltegravir (Isentress) treats HIV-1 infection, always alongside other HIV medicines, by blocking integrase, the enzyme HIV needs to insert itself into your cells' DNA; the first drug of its kind, it has been around for over a decade, is available as a generic, and is now often a second choice behind newer once-daily options. It is one of the gentler HIV medicines, and what people notice most is trouble sleeping, headache, nausea or vivid dreams. Its main warning is a severe rash or allergic reaction, which can be life-threatening, so stop it and get help right away if a rash comes with fever, blisters, mouth sores or facial swelling.

Clinical pearls

  • Avoid antacids containing aluminum or magnesium, because they lower raltegravir levels and spacing the doses apart does not fix it.
  • Do not swap between the regular tablets, chewable tablets and liquid, and always swallow the regular tablets whole.
  • Make sure any doctor starting rifampin, carbamazepine, phenytoin or phenobarbital knows you take raltegravir, since these can lower its levels.
  • The chewable tablets contain phenylalanine, which matters for anyone with phenylketonuria (PKU).
How you get itPrescription only
Comes asTablet, Chewable tablet, Oral suspension
Earliest FDA record2001
Companies listing it with the FDA5
FDA label last updatedOct 1, 2024
FDA’s strongest warning (boxed)None on the label

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

What Raltegravir is used for

▾

Raltegravir treats HIV-1 infection when used with other HIV medicines.

  • Isentress and Raltegravir tablets: adults, and children weighing at least 2 kg.
  • Isentress HD: adults, and children weighing at least 40 kg.
  • Isentress chewable tablets and oral suspension: part of the Isentress product line for children.

How Raltegravir works

▾

Raltegravir is an HIV-1 antiviral in the integrase strand transfer inhibitor class. In a short study of raltegravir alone, it lowered the amount of virus in the blood quickly. That is why it is combined with other HIV medicines for treatment.

Raltegravir dosage

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Raltegravir is taken by mouth, once or twice daily depending on the product and your situation. It can be taken with or without food.

  • Film-coated tablets must be swallowed whole.
  • Isentress chewable tablets may be chewed or swallowed whole.
  • Isentress oral suspension is mixed with water and used within 30 minutes.
  • Do not swap the chewable tablet or suspension for the regular tablet.

Follow your prescriber and the label for your exact dose.

Dosing details from the FDA-approved label

From the Raltegravir 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: treatment-naïve patients or patients virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily
    • 1200 mg (2 × 600 mg) film-coated tablet orally, once daily or 400 mg film-coated tablet orally, twice daily
    • Can be taken with or without food; 1200 mg once daily uses ISENTRESS HD 600 mg tablets
  • Adults: treatment-experienced patients
    • 400 mg film-coated tablet orally, twice daily
    • Can be taken with or without food
  • Adults: treatment-naïve or treatment-experienced when coadministered with rifampin
    • 800 mg (2 × 400 mg) twice daily
    • Coadministration with rifampin
  • Pediatrics: at least 40 kg and either treatment-naïve or virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily
    • 400 mg film-coated tablet twice daily, or 1200 mg (2 × 600 mg) once daily, or 300 mg (3 × 100 mg) chewable tablets twice daily
    • Weighing at least 40 kg
  • Pediatrics: at least 25 kg
    • One 400 mg film-coated tablet orally, twice daily
    • Weight-based chewable tablet dosing twice daily if unable to swallow a tablet (Table 3)
    • Maximum: Chewable tablets: 300 mg taken by mouth twice daily
    • Chewable tablet if unable to swallow a tablet; 25 to less than 28 kg: 150 mg twice daily; 28 to less than 40 kg: 200 mg twice daily
  • Pediatrics: at least 4 weeks of age and weighing at least 3 kg to less than 25 kg
    • Weight-based dosing twice daily using chewable tablet or oral suspension (Table 4), e.g. 3 to less than 4 kg: 2.5 mL (25 mg) twice daily
    • 14 to less than 20 kg: 10 mL (100 mg) twice daily
    • Maximum: Oral suspension: 100 mg taken by mouth twice daily
    • Based on approximately 6 mg/kg/dose twice daily; oral suspension up to 20 kg
  • Neonates: birth to 4 weeks (28 days) weighing at least 2 kg
    • Weight-based dosing of the oral suspension once daily or twice daily (Table 5)
    • Oral suspension only
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION ISENTRESS and ISENTRESS HD can be administered with or without food ( 2.1 ). Do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg or 600 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension ( 2.1 ). Adults Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily: 1200 mg (2 × 600 mg) film-coated tablet orally, once daily or 400 mg film-coated tablet orally, twice daily ( 2.2 ). Treatment-experienced patients: 400 mg film-coated tablet orally, twice daily ( 2.2 ). During coadministration with rifampin in adults, 800 mg (2 × 400 mg) twice daily ( 2.2 ). Pediatrics If weighing at least 40 kg, and either treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily: 1200 mg (2 × 600 mg) film-coated tablet orally, once daily or 400 mg film-coated tablet orally, twice daily or 300 mg (3 × 100 mg) chewable tablets, twice daily ( 2.3 ). If weighing at least 25 kg: One 400 mg film-coated tablet orally, twice daily. If unable to swallow a tablet, consider the chewable tablet, as specified in Table 2 ( 2.3 ). If weighing at least 3 kg to less than 25 kg: Weight-based dosing using the chewable tablet or oral suspension, as specified in Table 4 ( 2.3 ). For neonates (birth to 4 weeks [28 days] of age): Weight-based dosing of the oral suspension as specified in Table 5 ( 2.3 ). 2.1 General Dosing Recommendations Because the formulations have different pharmacokinetic profiles, do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg film-coated tablet or the ISENTRESS HD 600 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension. Because the extent to which ISENTRESS may be dialyzable is unknown, dosing before a dialysis session should be avoided [see Clinical Pharmacology (12.3) ] . ISENTRESS film-coated tablets must be swallowed whole. ISENTRESS chewable tablets may be chewed or swallowed whole. Maximum daily dose is 300 mg taken by mouth twice daily. For children who have difficulty chewing the 25 mg chewable tablet, the tablet may be crushed.

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

Raltegravir side effects

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Most people tolerate raltegravir well. Common effects include:

Common side effects

  • Trouble sleeping (insomnia)
  • Headache
  • Dizziness
  • Nausea
  • Tiredness (fatigue)
  • Diarrhea
  • Decreased appetite
  • Abnormal dreams or nightmares

When to get medical help

  • Get help right away for a severe rash, or a rash with fever, blisters, mouth sores, red eyes, or facial swelling. Stop the medicine and call your doctor.
  • Call your doctor if you feel generally unwell, very tired, or have muscle or joint aches with a rash. These can signal a serious allergic-type reaction.
  • Report signs of liver trouble, such as hepatitis or abnormal liver tests, to your doctor right away.
  • Tell your doctor about unexplained muscle pain or weakness. Muscle breakdown (rhabdomyolysis) and muscle disease (myopathy) have been reported.
  • Tell your doctor if new symptoms of infection or inflammation appear soon after starting HIV treatment. This can be immune reconstitution syndrome.

Raltegravir warnings and precautions

▾
  • Severe skin and allergic reactions can be life-threatening. Stop the medicine and get help right away if you see warning signs.
  • Immune reconstitution syndrome can occur early in HIV treatment as your immune system recovers.
  • Muscle problems such as myopathy and rhabdomyolysis have been reported.
  • Isentress chewable tablets contain phenylalanine.

Raltegravir interactions

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Some medicines can change raltegravir levels.

  • Rifampin lowers levels, so the dose changes with Isentress. It is not recommended with Isentress HD.
  • Aluminum or magnesium antacids lower levels, so avoid taking them together.
  • Carbamazepine, phenobarbital and phenytoin may lower levels.
  • Drugs that block UGT1A1 may raise levels.

Interactions listed in the FDA-approved label

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

  • Aluminum and/or magnesium-containing antacids: Decreases raltegravir concentration. Coadministration or staggered administration is not recommended.
  • Calcium carbonate antacid: Decreases raltegravir concentration. ISENTRESS: no dose adjustment; ISENTRESS HD: co-administration is not recommended.
  • Rifampin: Strong UGT1A1 inducer; decreases raltegravir concentration. ISENTRESS: 800 mg twice daily during coadministration; no data in patients below 18 years of age. ISENTRESS HD: coadministration is not recommended.
  • Tipranavir/ritonavir: No clinically meaningful effect on raltegravir pharmacokinetics. ISENTRESS: no dose adjustment; ISENTRESS HD: coadministration is not recommended.
  • Etravirine: Decreases raltegravir concentration. ISENTRESS: no dose adjustment; ISENTRESS HD: coadministration is not recommended.
  • Other strong inducers of drug metabolizing enzymes (e.g., carbamazepine, phenobarbital, phenytoin): May decrease raltegravir concentration; impact is unknown. Coadministration is not recommended (ISENTRESS HD).
  • UGT1A1 inhibitors: May increase plasma levels of raltegravir.
  • Atazanavir, atazanavir/ritonavir, boceprevir, darunavir/ritonavir, efavirenz, omeprazole: No clinically meaningful effect on raltegravir pharmacokinetics. No dose adjustment required.
  • Ethinyl estradiol/norgestimate, methadone, midazolam, lamivudine, tenofovir disoproxil fumarate: Raltegravir did not have a clinically meaningful effect on their pharmacokinetics. No dose adjustment required.
  • Tenofovir alafenamide: No predicted pharmacokinetic drug interaction.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Coadministration of ISENTRESS or ISENTRESS HD and other drugs may alter the plasma concentration of raltegravir. The potential for drug-drug interactions must be considered prior to and during therapy ( 7 ). • Coadministration of ISENTRESS or ISENTRESS HD with drugs that are strong inducers of UGT1A1, such as rifampin, may result in reduced plasma concentrations of raltegravir ( 2.1 , 7.1 ). 7.1 Effect of Other Agents on the Pharmacokinetics of Raltegravir Raltegravir is not a substrate of cytochrome P450 (CYP) enzymes. Based on in vivo and in vitro studies, raltegravir is eliminated mainly by metabolism via a UGT1A1-mediated glucuronidation pathway. Coadministration of ISENTRESS with drugs that inhibit UGT1A1 may increase plasma levels of raltegravir and coadministration of ISENTRESS with drugs that induce UGT1A1, such as rifampin, may reduce plasma levels of raltegravir (see Table 11 ). Selected drug interactions are presented in Table 11 [see Clinical Pharmacology (12.3) ] . In some cases, recommendations differ for ISENTRESS versus ISENTRESS HD. Table 11: Selected Drug Interactions in Adults Concomitant Drug Class: Drug Name Effect on Concentration of Raltegravir Clinical Comment for ISENTRESS Clinical Comment for ISENTRESS HD Metal-Containing Antacids Aluminum and/or magnesium-containing antacids ↓ Coadministration or staggered administration is not recommended. Calcium carbonate antacid ↓ No dose adjustment Co-administration is not recommended Other Agents Rifampin ↓ The recommended dosage is 800 mg twice daily during coadministration with rifampin. There are no data to guide co-administration of ISENTRESS with rifampin in patients below 18 years of age [see Dosage and Administration (2.1) ]. Coadministration is not recommended. Tipranavir/ritonavir No dose adjustment Coadministration is not recommended Etravirine ↓ No dose adjustment Coadministration is not recommended.

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 Raltegravir

▾
  • Tell your prescriber about all medicines, especially rifampin and antacids.
  • Mention any past muscle problems or high creatine kinase.
  • Mention phenylketonuria if you will use the chewable tablets.
  • Discuss pregnancy plans. A pregnancy registry exists.
  • Women with HIV are advised not to breastfeed.

Raltegravir overdose

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No specific treatment for overdose is known. In studies, high doses did not show toxicity in healthy volunteers. If you take too much, get medical help, where supportive care and heart monitoring may be used.

What Raltegravir does in the body

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In a short study, raltegravir lowered viral load rapidly, by about 1.66 log10 copies/mL by day 10. At a higher-than-normal dose it did not meaningfully prolong the QT interval, a heart rhythm measure.

How your body processes Raltegravir

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Raltegravir is absorbed within a few hours and reaches steady levels in about 2 days. Its half-life is about 9 hours. The body clears it mainly through a liver process called glucuronidation (UGT1A1), and it leaves through feces and urine. The chewable tablet and suspension are absorbed more fully than the 400 mg tablet, which is why they are not interchangeable.

How to store Raltegravir

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Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Store in the original package with the bottle tightly closed. protect from moisture.

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

33

Supplements & herbs that interact with Raltegravir

33 supplements and herbal products have documented interactions with Raltegravir 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 · 1
  • Moderate · 22
  • Minor · 10
Every supplement checked against Raltegravir — ranked by severity The full interaction hub: 1 major · 22 moderate · 10 minor · every one linked to its full report. Check Raltegravir 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.

Raltegravir: pharmacist answers to common questions

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

What is raltegravir for?

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It treats HIV-1 infection and is always used with other HIV medicines. Different products are approved for different ages and weights, so your prescriber picks the right one for you.

Do I need to take it with food?

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No. It can be taken with or without food. Swallow the regular tablets whole.

Can I switch between the tablet, chewable tablet and suspension?

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No. The forms are absorbed differently, so they are not interchangeable. Only switch if your prescriber tells you to.

What side effects should I expect?

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The most common are trouble sleeping, headache, dizziness, nausea and tiredness. These are usually manageable. Tell your doctor if they bother you.

When should I call my doctor right away?

▾
Call right away for a severe rash, blisters, mouth sores, facial swelling, or a rash with fever or feeling ill. Stop the medicine and get help. Also report unexplained muscle pain or weakness.

Do other medicines affect it?

▾
Yes. Rifampin and antacids with aluminum or magnesium can lower raltegravir levels. Tell me about everything you take so we can check.

Is Raltegravir available over the counter?

▾
No. Raltegravir is a prescription medicine: every Raltegravir 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 Raltegravir first available?

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The earliest FDA record we hold for Raltegravir is from 2001: 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 Raltegravir was first used.

Who makes Raltegravir?

▾
5 companies currently list Raltegravir products in the FDA's NDC Directory, including Merck Sharp & Dohme LLC, A-S Medication Solutions, Camber Pharmaceuticals, Inc.. 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 Raltegravir on HelloPharmacist

Detailed data & references for Raltegravir 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.

Raltegravir forms and strengths (how it comes)

Raltegravir is available in 3 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.

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

Tablet

By mouth
Brands Isentress
How this form is used
What it may be used for
  • Isentress and Raltegravir tablets are used with other HIV medicines for HIV-1 infection in adults and children weighing at least 2 kg.
  • Isentress HD is used in adults and in children weighing at least 40 kg.
Important instructions
  • Isentress and Raltegravir film-coated tablets must be swallowed whole.
  • Isentress and Raltegravir tablets can be taken with or without food.
  • Raltegravir tablets should not be replaced with Isentress chewable tablets or oral suspension.
  • Avoid dosing Isentress or Raltegravir tablets right before dialysis.
Available strengths 2 strengths
19 FDA-listed product records ⓘ

Chewable tablet

By mouth
Brands Isentress
How this form is used
What it may be used for
  • Isentress is used with other HIV medicines for HIV-1 infection in children weighing at least 2 kg.
Important instructions
  • Isentress chewable tablets may be chewed or swallowed whole.
  • Isentress chewable tablets are not a substitute for the regular film-coated tablets.
  • Isentress chewable tablets contain phenylalanine, which matters for people with phenylketonuria.
  • Isentress chewable tablets can be taken with or without food.
Available strengths 2 strengths
8 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Isentress
How this form is used
What it may be used for
  • Isentress is used with other HIV medicines for HIV-1 infection in children weighing at least 2 kg.
Important instructions
  • Isentress for oral suspension is mixed with water in the mixing cup provided. Gently swirl it and do not shake.
  • Give Isentress oral suspension within 30 minutes of mixing, and discard any leftover.
  • Isentress for oral suspension is not a substitute for the regular film-coated tablets.
  • Isentress for oral suspension can be taken with or without food.
Available strengths 2 strengths
4 FDA-listed product records ⓘ

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

How Raltegravir 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.

5 companies list 9 Raltegravir product records with the FDA, mostly as tablet, chewable tablet, oral suspension; the earliest marketing or approval year on record is 2001. Brand names on the directory include Isentress, Isentress HD; the rest are generics.

3
Dose forms ⓘ
5
Labelers (makers, repackagers, distributors)
2
Brand names
9
FDA-listed product records ⓘ
2001
Earliest FDA record ⓘ

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 (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Merck Sharp & Dohme LLC56%
A-S Medication Solutions11%
Camber Pharmaceuticals, Inc.11%
NuCare Pharmaceuticals,Inc.11%
Proficient Rx LP11%

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

How widely Raltegravir is used (Medicaid data)

A general measure of how commonly Raltegravir 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 Raltegravir 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.

16,834
Medicaid prescriptions filled (Q1–Q4 2025)
$33.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Raltegravir prescribed? Of the 1,601 medications we measure, Raltegravir ranks #831 by Medicaid prescriptions — more than 48% of them.

Where Raltegravir ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Raltegravir 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.

The 400 mg oral tablet is the most-dispensed Raltegravir product — about 81% of these Medicaid prescriptions.

raltegravir 400 MG Oral Tablet Most dispensed

13,685 Medicaid prescriptions (Q1–Q4 2025) 81% of Raltegravir prescriptions shown $27.4M gross reimbursement (before rebates) ≈ $2,000 per prescription (gross)

Summed across the 1 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 744842

raltegravir 600 MG Oral Tablet

3,089 Medicaid prescriptions (Q1–Q4 2025) 18% of Raltegravir prescriptions shown $6.5M gross reimbursement (before rebates) ≈ $2,094 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1924313

raltegravir 100 MG Chewable Tablet

60 Medicaid prescriptions (Q1–Q4 2025) <1% of Raltegravir prescriptions shown $49,336 gross reimbursement (before rebates) ≈ $822 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1235588

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 Raltegravir, 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 3 of 23 listed Raltegravir NDCs with Medicaid activity.

Compare Raltegravir products

A representative set of FDA-listed product records for Raltegravir — 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
💊Chewable tablet
25 mg Oral Merck Sharp & Dohme LLC NDA View NDC →
100 mg Oral Merck Sharp & Dohme LLC NDA View NDC →
💊Oral suspension
100 mg Oral Merck Sharp & Dohme LLC NDA View NDC →
💊Tablet
400 mg Oral A-S Medication Solutions NDA View NDC →
400 mg Oral Camber Pharmaceuticals, Inc. ANDA View NDC →
400 mg Oral Merck Sharp & Dohme LLC NDA View NDC →
600 mg Oral Merck Sharp & Dohme LLC NDA View NDC →
400 mg Oral NuCare Pharmaceuticals,Inc. NDA View NDC →
400 mg Oral Proficient Rx LP NDA View NDC →

Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Raltegravir NDCs →

Raltegravir 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 Raltegravir recalls since July 2021.

✅No Raltegravir 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 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.

Ingredient (IN) Raltegravir RxCUI 719872 3 dose forms · 5 strengths
  1. Dose form (SCDF) Chewable Tablet RxCUI 1235587 In current FDA listings
    Clinical drug / strength (SCD) 25 MG RxCUI 1235593 100 MG RxCUI 1235588
  2. Dose form (SCDF) Granules for Oral Suspension RxCUI 1855367 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 1486838
  3. Dose form (SCDF) Oral Tablet RxCUI 744841 In current FDA listings
    Clinical drug / strength (SCD) 400 MG RxCUI 744842 600 MG RxCUI 1924313

Look up RxCUI 719872 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 Raltegravir 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 400 mg $34.54 per tablet NDC details & price history
Tablet, Film Coated · Oral 600 mg $34.52 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.

Raltegravir brand names

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

Isentress Isentress HD

Who makes Raltegravir: manufacturers and labelers

5 companies list Raltegravir products with the FDA. By number of product records, the largest are Merck Sharp & Dohme LLC, A-S Medication Solutions, Camber Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Merck Sharp & Dohme LLC 5 A-S Medication Solutions 1 Camber Pharmaceuticals, Inc. 1 NuCare Pharmaceuticals,Inc. 1 Proficient Rx LP 1

Raltegravir drug class (RxNorm)

Raltegravir belongs to the Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Drug family (ATC) Integrase inhibitors
How it works HIV Integrase 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 Raltegravir 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.

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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 Oct 1, 2024
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Raltegravir.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Raltegravir after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
6
Finished products in the current FDA directory
9
Companies listing them (makers, repackagers, distributors)
5
FDA labeler codes behind them ⓘ
5
Linked representative label ⓘ
Proficient Rx LP
Linked label effective
Oct 1, 2024
Composite sections available
24
Linked SPL Set ID
ccc6f2f9-696f-4ef9-bb4c-e0198d957b0b
Linked SPL Document ID
4cb3ef64-0fec-45c7-9c7f-5cca90c7a517
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. Proficient Rx 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 →