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Efavirenz

Efavirenz is an antiviral medicine (a non-nucleoside reverse transcriptase inhibitor) used together with other HIV medicines to treat HIV-1 infection in adults and children at least 3 months old who weigh at least 3.5 kg.

Brand name Sustiva
Drug class Human Immunodeficiency Virus 1 Non-nucleoside Analog Reverse Transcriptase Inhibitor
Rx Forms 2
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 5, 2026
Efavirenz 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

Efavirenz (Sustiva) treats HIV-1 infection as part of a combination regimen, blocking reverse transcriptase, an enzyme the virus needs to copy itself; on the U.S. market since about 1997 and available generically, it was long a first-choice HIV medicine but is now more of an older standby. It is harder on the nervous system than newer options, and early on many people notice dizziness, vivid dreams, trouble sleeping or poor concentration, which usually ease within a few weeks. The thing to watch most closely is mood, so get help right away for depression, suicidal thoughts, paranoia or aggressive behavior, and report a severe rash or signs of liver trouble.

Clinical pearls

  • Take it on an empty stomach at bedtime, because food raises efavirenz levels and side effects, and sleeping eases the dizziness.
  • Never take efavirenz on its own or skip doses, because HIV can quickly become resistant to it.
  • If you could become pregnant, back up hormonal birth control with a barrier method until 12 weeks after stopping efavirenz.
  • Efavirenz changes levels of many drugs, including warfarin, statins, seizure medicines and methadone, so every new prescription deserves an interaction check.
How you get itPrescription only
Comes asTablet, Capsule
Earliest FDA record1997
Companies listing it with the FDA5
FDA label last updatedJun 28, 2024
FDA’s strongest warning (boxed)None on the label

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

What Efavirenz is used for

▾

Efavirenz is used to treat HIV-1 infection.

  • Efavirenz tablets treat HIV-1 infection in combination with other antiretroviral medicines, in adults and children at least 3 months old weighing at least 3.5 kg.
  • Efavirenz capsules are labeled for the same use and the same age and weight groups.

How Efavirenz works

▾

Efavirenz is an antiviral drug in the class called non-nucleoside reverse transcriptase inhibitors. It is used together with other HIV medicines as a combination regimen.

Efavirenz dosage

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Efavirenz is taken by mouth once a day, preferably at bedtime on an empty stomach. Food can raise efavirenz levels and may increase side effects.

  • Swallow it whole with liquid.
  • Efavirenz tablets must not be broken.
  • Children's doses depend on weight.
  • It must always be taken with other HIV medicines.

Follow your prescriber's directions and the label.

Dosing details from the FDA-approved label

From the Efavirenz 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
    • 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs)
    • Take on an empty stomach, preferably at bedtime
  • Adults taking voriconazole
    • Efavirenz decreased to 300 mg once daily using the capsule formulation (one 200 mg and two 50 mg capsules or six 50 mg capsules)
    • Voriconazole maintenance dose increased to 400 mg every 12 hours
    • Efavirenz tablets must not be broken
  • Adults taking rifampin (patients weighing 50 kg or more)
    • 800 mg efavirenz once daily
    • Applies to patients weighing 50 kg or more
  • Pediatric patients weighing 3.5 kg to less than 5 kg
    • 100 mg daily (two 50 mg capsules)
    • Age 3 months or older
  • Pediatric patients weighing 5 kg to less than 7.5 kg
    • 150 mg daily (three 50 mg capsules)
    • Age 3 months or older
  • Pediatric patients weighing 7.5 kg to less than 15 kg
    • 200 mg daily (one 200 mg capsule)
    • Age 3 months or older
  • Pediatric patients weighing 15 kg to less than 20 kg
    • 250 mg daily (one 200 mg + one 50 mg capsule)
    • Age 3 months or older
  • Pediatric patients weighing 20 kg to less than 25 kg
    • 300 mg daily (one 200 mg + two 50 mg capsules)
    • Age 3 months or older
  • Pediatric patients weighing 25 kg to less than 32.5 kg
    • 350 mg daily (one 200 mg + three 50 mg capsules)
    • Age 3 months or older
  • Pediatric patients weighing 32.5 kg to less than 40 kg, and at least 40 kg
    • 32.5 kg to less than 40 kg: 400 mg daily (two 200 mg capsules)
    • At least 40 kg: 600 mg once daily (one 600 mg tablet OR three 200 mg capsules)
    • Tablets must not be crushed
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Efavirenz capsules should be taken orally once daily on an empty stomach, preferably at bedtime. ( 2 ) Recommended adult dose: 600 mg. ( 2.2 ) With voriconazole, increase voriconazole maintenance dose to 400 mg every 12 hours and decrease efavirenz dose to 300 mg once daily using the capsule formulation. (2.2) With rifampin, increase efavirenz capsules dose to 800 mg once daily for patients weighing 50 kg or more. (2.2) Pediatric dosing is based on weight. (2.3) 2.1 Hepatic Function Monitor hepatic function prior to and during treatment with efavirenz capsules [see Warnings and Precautions (5.9) ] . Efavirenz capsules are not recommended in patients with moderate or severe hepatic impairment (Child Pugh B or C) [see Warnings and Precautions (5.9) and Use in Specific Populations (8.6) ] . 2.2 Adults The recommended dosage of efavirenz capsules is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs). It is recommended that efavirenz capsules be taken on an empty stomach, preferably at bedtime. The increased efavirenz concentrations observed following administration of efavirenz capsules with food may lead to an increase in frequency of adverse reactions [see Clinical Pharmacology (12.3) ]. Dosing at bedtime may improve the tolerability of nervous system symptoms [see Warnings and Precautions (5.6) , Adverse Reactions (6.1) , and Patient Counseling Information (17) ]. Efavirenz capsules should be swallowed intact with liquid. For patients who cannot swallow capsules, the capsule sprinkle method of administration is recommended [see Dosage and Administration (2.4) ]. Concomitant Antiretroviral Therapy Efavirenz capsules must be given in combination with other antiretroviral medications [see Indications and Usage (1) , Warnings and Precautions (5.3) , Drug Interactions (7.1) , and Clinical Pharmacology (12.3) ] . Dosage Adjustment If efavirenz capsules are coadministered with voriconazole, the voriconazole maintenance dose should be increased to 400 mg every 12 hours and the efavirenz dose should be decreased to 300 mg once daily using the capsule formulation (one 200 mg and two 50 mg capsules or six 50 mg capsules).

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

Efavirenz side effects

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Many people notice side effects early on, and they often ease within a few weeks.

Common side effects

  • Rash
  • Dizziness
  • Headache
  • Nausea and vomiting
  • Tiredness (fatigue)
  • Trouble sleeping (insomnia)
  • Trouble concentrating
  • Abnormal dreams

When to get medical help

  • Get help right away for severe depression, thoughts of suicide, aggressive behavior, paranoia, or mania.
  • Call your doctor if you develop a severe rash, especially with blistering, peeling skin, mouth sores, or fever.
  • Seek care for signs of liver problems, since serious hepatitis and liver failure have been reported.
  • Tell your doctor about hallucinations, confusion, poor balance, or other serious nervous system symptoms, even months or years after starting.
  • Report seizures, which have been seen in people taking efavirenz.
  • Report new symptoms after starting HIV treatment, since immune reconstitution syndrome may need further evaluation and treatment.
  • Tell your doctor if you have a fast or irregular heartbeat or faint, because efavirenz can prolong the QTc interval (a heart rhythm change).

Efavirenz warnings and precautions

▾
  • Mental health effects: severe depression, suicidal thoughts, aggression, paranoia, and mania have been reported. Get immediate medical evaluation.
  • Nervous system symptoms: dizziness, insomnia, and abnormal dreams are common. Late-onset problems like poor balance and confusion can occur months to years later.
  • Liver injury: serious hepatitis and liver failure have been reported, so liver tests are done before and during treatment.
  • Rash: usually mild, but stop and call your doctor if it is severe.
  • Other risks: seizures, QTc prolongation, higher cholesterol and triglycerides, immune reconstitution syndrome, and body fat changes.
  • Resistance: never use it alone for HIV-1.

Efavirenz interactions

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Efavirenz affects liver enzymes (CYP3A and CYP2B6), so it can change levels of many other drugs.

  • Elbasvir/grazoprevir: must not be used together.
  • Voriconazole and rifampin: efavirenz doses are adjusted.
  • Other NNRTIs, Atripla, and several hepatitis C medicines: not recommended with efavirenz.
  • QT-prolonging drugs: consider alternatives because of heart rhythm risk.
  • Hormonal contraceptives: may be less reliable, so add barrier contraception.
  • Warfarin, anticonvulsants, statins, and immunosuppressants: levels may change and monitoring or dose changes may be needed.
  • Alcohol and psychoactive drugs: can add to nervous system effects.

Interactions listed in the FDA-approved label

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

  • Voriconazole: Decreases voriconazole and increases efavirenz concentrations. Should not be coadministered at standard doses; increase voriconazole maintenance dose to 400 mg every 12 hours and decrease efavirenz to 300 mg once daily using the capsule formulation.
  • Rifampin: Decreases efavirenz concentrations. Increase efavirenz to 800 mg once daily when coadministered with rifampin to patients weighing 50 kg or more.
  • Rifabutin: Decreases rifabutin concentrations. Increase daily dose of rifabutin by 50%. Consider doubling the rifabutin dose in regimens where rifabutin is given 2 or 3 times a week.
  • Elbasvir/Grazoprevir: Decreases elbasvir and grazoprevir; may lead to loss of virologic response. Coadministration is contraindicated.
  • Other NNRTIs: Increase or decrease efavirenz and/or the NNRTI. Combining two NNRTIs has not been shown to be beneficial; efavirenz should not be coadministered with other NNRTIs.
  • Atazanavir: Decreases atazanavir. Treatment-naive: atazanavir 400 mg with ritonavir 100 mg once daily with food and efavirenz 600 mg once daily on an empty stomach, preferably at bedtime. Treatment-experienced: coadministration not recommended.
  • Warfarin: Increases or decreases warfarin. Monitor INR and adjust warfarin dosage if necessary.
  • Hormonal contraceptives (oral ethinyl estradiol/norgestimate; implant etonogestrel): Active metabolites of norgestimate increased; etonogestrel decreased, with postmarketing reports of contraceptive failure with etonogestrel. Use a reliable method of barrier contraception in addition to hormonal contraceptives.
  • QT prolonging drugs / clarithromycin / artemether-lumefantrine: QTc prolongation has been observed with efavirenz; limited information on interaction with drugs that prolong QTc. Consider alternatives to efavirenz with a drug with known risk of Torsade de Pointes; consider alternatives to macrolide antibiotics and to artemether/lumefantrine.
  • Immunosuppressants (cyclosporine, tacrolimus, sirolimus and others metabolized by CYP3A): Immunosuppressant concentrations decrease. Dose adjustments may be required; monitor concentrations for at least 2 weeks (until stable) when starting or stopping efavirenz.
Read the label’s full interactions text

5.1 Drug Interactions Efavirenz plasma concentrations may be altered by substrates, inhibitors, or inducers of CYP3A. Likewise, efavirenz may alter plasma concentrations of drugs metabolized by CYP3A or CYP2B6. The most prominent effect of efavirenz at steady state is induction of CYP3A and CYP2B6 [see Dosage and Administration ( 2.2 ) and Drug Interactions ( 7.1 )].

7 DRUG INTERACTIONS Coadministration of efavirenz can alter the concentrations of other drugs and other drugs may alter the concentrations of efavirenz. The potential for drug-drug interactions should be considered before and during therapy. ( 7 ) 7.1 Potential for Efavirenz to Affect other Drugs Efavirenz has been shown in vivo to induce CYP3A and CYP2B6. Other compounds that are substrates of CYP3A or CYP2B6 may have decreased plasma concentrations when coadministered with efavirenz. 7.2 Potential for Other Drugs to Affect Efavirenz Drugs that induce CYP3A activity (e.g., phenobarbital, rifampin, rifabutin) would be expected to increase the clearance of efavirenz resulting in lowered plasma concentrations [ see Dosage and Administration ( 2.2 ) ]. 7.3 QT Prolonging Drugs There is limited information available on the potential for a pharmacodynamic interaction between efavirenz and drugs that prolong the QTc interval. QTc prolongation has been observed with the use of efavirenz [see Clinical Pharmacology ( 12.2 )] . Consider alternatives to efavirenz when coadministered with a drug with a known risk of Torsade de Pointes. 7.4 Established and Other Potentially Significant Drug Interactions Drug interactions with efavirenz are summarized in Table 5. For pharmacokinetics data, [see Clinical Pharmacology ( 12.3 )] Tables 7 and 8 . This table includes potentially significant interactions, but is not all inclusive.

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 Efavirenz

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  • Do not use it if you have had a serious skin reaction to efavirenz.
  • Avoid it in the first trimester of pregnancy. Get a pregnancy test first and use effective contraception during treatment and for 12 weeks after.
  • Breastfeeding is not recommended for mothers with HIV.
  • Tell your doctor about liver disease, seizures, or mental health history.
  • It is not recommended with moderate or severe liver impairment.
  • Children under 3 months or 3.5 kg should not take it. Rash is more common in children.
  • Older adults need cautious dose selection.

Efavirenz overdose

▾

Some people who accidentally took twice the usual daily amount had stronger nervous system symptoms, and one had involuntary muscle contractions. Treatment is supportive care with monitoring, and activated charcoal may be used. There is no specific antidote, and dialysis is unlikely to help. Call poison control or seek emergency care.

What Efavirenz does in the body

▾

Efavirenz can prolong the QTc interval, a measure of the heart's electrical rhythm. In a study, the effect was larger in people with a genetic variant (CYP2B6 *6/*6) that raises efavirenz levels.

How your body processes Efavirenz

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Efavirenz peaks in the blood about 3 to 5 hours after a dose. Steady levels are reached in 6 to 10 days. Food raises absorption, which is why it is taken on an empty stomach. It is mostly broken down by the liver (CYP3A and CYP2B6) and also speeds up its own breakdown. Its half-life is about 40 to 55 hours with repeated dosing, and it leaves the body mainly through feces and urine as metabolites.

How to store Efavirenz

▾

Efavirenz capsules should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

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

159

Supplements & herbs that interact with Efavirenz

159 supplements and herbal products have documented interactions with Efavirenz 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 · 3
  • Moderate · 117
  • Minor · 39
Every supplement checked against Efavirenz — ranked by severity The full interaction hub: 3 major · 117 moderate · 39 minor · every one linked to its full report. Check Efavirenz 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.

1

Nutrient depletion considerations

Efavirenz has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Efavirenz nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Efavirenz: pharmacist answers to common questions

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

What is efavirenz for?

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It treats HIV-1 infection. You take it together with other HIV medicines, never alone. It is used in adults and in children at least 3 months old who weigh at least 3.5 kg.

When should I take it?

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Take it once a day on an empty stomach, ideally at bedtime. Food can raise the drug level and may make side effects worse. Bedtime dosing can make dizziness and similar symptoms easier to handle.

What side effects should I expect?

▾
Dizziness, vivid dreams, trouble sleeping, headache, nausea, and rash are common. Nervous system symptoms usually start in the first day or two and improve in 2 to 4 weeks. Rash usually shows up in the first couple of weeks and often clears within a month.

When should I call my doctor right away?

▾
Call for severe depression, thoughts of suicide, unusual aggression or paranoia, or a severe rash with blisters, peeling, mouth sores, or fever. Also call for signs of liver trouble or a seizure. Don't wait on these.

Can I drink alcohol or take other medicines with it?

▾
Alcohol can add to the dizziness and drowsiness. Efavirenz also interacts with many medicines, including some hepatitis C drugs, voriconazole, rifampin, and birth control. Always check with me before starting anything new.

Is it safe in pregnancy?

▾
It should be avoided in the first trimester because of a possible risk of birth defects. If you could become pregnant, you should take a pregnancy test first and use effective contraception, including a barrier method, during treatment and for 12 weeks after stopping. Talk with your doctor if you are pregnant or planning to be.

Is Efavirenz available over the counter?

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

▾
The earliest FDA record we hold for Efavirenz is from 1997: 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 Efavirenz was first used.

Who makes Efavirenz?

▾
5 companies currently list Efavirenz products in the FDA's NDC Directory, including Aurobindo Pharma Limited, Camber Pharmaceuticals, Inc., Cipla USA 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 Efavirenz on HelloPharmacist

Detailed data & references for Efavirenz 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.

Efavirenz forms and strengths (how it comes)

Efavirenz 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

By mouth
Brands Sustiva
How this form is used
What it may be used for
  • Efavirenz tablets are used with other antiretroviral medicines to treat HIV-1 infection in adults and in children at least 3 months old weighing at least 3.5 kg.
Important instructions
  • Efavirenz tablets are taken once daily on an empty stomach, preferably at bedtime.
  • Efavirenz tablets should be swallowed whole with liquid.
  • Efavirenz tablets must not be broken.
Available strengths 1 strength
11 FDA-listed product records ⓘ

Capsule

By mouth
Brands Sustiva
How this form is used
What it may be used for
  • Efavirenz capsules are used with other antiretroviral medicines to treat HIV-1 infection in adults and in children at least 3 months old weighing at least 3.5 kg.
Important instructions
  • Efavirenz capsules are taken once daily on an empty stomach, preferably at bedtime.
  • Efavirenz capsules should be swallowed whole with liquid.
  • For people who cannot swallow capsules, the label recommends the capsule sprinkle method for efavirenz capsules.
Available strengths 3 strengths
9 FDA-listed product records ⓘ

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

How Efavirenz 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 8 Efavirenz product records with the FDA, mostly as tablet, capsule; the earliest marketing or approval year on record is 1997. Brand names on the directory include Sustiva; the rest are generics.

2
Dose forms ⓘ
5
Labelers (makers, repackagers, distributors)
1
Brand names
8
FDA-listed product records ⓘ
1997
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 (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Aurobindo Pharma Limited50%
Camber Pharmaceuticals, Inc.13%
Cipla USA Inc.13%
Macleods Pharmaceuticals Limited13%
XLCare Pharmaceuticals Inc.13%

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

How widely Efavirenz is used (Medicaid data)

A general measure of how commonly Efavirenz 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 Efavirenz 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.

694
Medicaid prescriptions filled (Q1–Q4 2025)
$55,140 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Efavirenz prescribed? Of the 1,601 medications we measure, Efavirenz ranks #1,332 by Medicaid prescriptions — more than 17% of them.

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

Utilization by Efavirenz 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.

efavirenz 600 MG Oral Tablet

694 Medicaid prescriptions (Q1–Q4 2025) 100% of Efavirenz prescriptions shown $55,140 gross reimbursement (before rebates) ≈ $79 per prescription (gross)

Summed across the 3 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349477

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 Efavirenz, 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 19 listed Efavirenz NDCs with Medicaid activity.

Compare Efavirenz products

A representative set of FDA-listed product records for Efavirenz — 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
💊Capsule
50 mg Oral Aurobindo Pharma Limited ANDA View NDC →
100 mg Oral Aurobindo Pharma Limited ANDA View NDC →
200 mg Oral Aurobindo Pharma Limited ANDA View NDC →
💊Tablet
600 mg Oral Aurobindo Pharma Limited ANDA View NDC →
600 mg Oral Camber Pharmaceuticals, Inc. ANDA View NDC →
600 mg Oral Cipla USA Inc. ANDA View NDC →
600 mg Oral Macleods Pharmaceuticals Limited ANDA View NDC →
600 mg Oral XLCare Pharmaceuticals Inc. ANDA View NDC →

Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Efavirenz NDCs →

Efavirenz 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 Efavirenz recalls since July 2021.

✅No Efavirenz 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) Efavirenz RxCUI 195085 3 dose forms · 6 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 372003 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 205292 100 MG RxCUI 205291 200 MG RxCUI 205290
  2. Dose form (SCDF) Oral Solution RxCUI 402423 No current FDA listing
    Clinical drug / strength (SCD) 30 MG/ML RxCUI 402008
  3. Dose form (SCDF) Oral Tablet RxCUI 378299 In current FDA listings
    Clinical drug / strength (SCD) 200 MG RxCUI 1088481 600 MG RxCUI 349477

Look up RxCUI 195085 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 Efavirenz 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 600 mg $1.28 per tablet NDC details & price history
Tablet, Film Coated 600 mg $1.28 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.

Efavirenz brand names

Efavirenz is sold under one brand name in the FDA directory — Sustiva. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Sustiva

Who makes Efavirenz: manufacturers and labelers

5 companies list Efavirenz products with the FDA. By number of product records, the largest are Aurobindo Pharma Limited, Camber Pharmaceuticals, Inc., Cipla USA Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Aurobindo Pharma Limited 4 Camber Pharmaceuticals, Inc. 1 Cipla USA Inc. 1 Macleods Pharmaceuticals Limited 1 XLCare Pharmaceuticals Inc. 1

Efavirenz drug class (RxNorm)

Efavirenz belongs to the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Drug family (ATC) Non-nucleoside reverse transcriptase inhibitors
How it works Non-Nucleoside Reverse Transcriptase Inhibitors, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 2C9 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 Efavirenz 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 Jun 28, 2024
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Efavirenz.
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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 Efavirenz after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
6
Finished products in the current FDA directory
8
Companies listing them (makers, repackagers, distributors)
5
FDA labeler codes behind them ⓘ
5
Linked representative label ⓘ
Macleods Pharmaceuticals Limited
Linked label effective
Jun 28, 2024
Composite sections available
22
Linked SPL Set ID
13ca3456-e5bf-4bb1-af95-b1378658a358
Linked SPL Document ID
f1a4251a-e04d-48aa-ae58-44b30df1de0d
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. Macleods Pharmaceuticals Limited 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 →