FDA-filed SPL labeling · retrieved through openFDA

Nevirapine

Nevirapine is an antiviral medication (NNRTI) used in combination with other HIV drugs to treat HIV-1 infection in adults and children.

Brand names ViramuneViramune XR
Drug class Human Immunodeficiency Virus 1 Non-nucleoside Analog Reverse Transcriptase Inhibitor
Rx Forms 3 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 9 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 →

At a glance
Linked label effectiveOct 15, 2024
Clinical labels in scope 9
AvailabilityRx
Earliest approval/marketing year 1996
FDA-listed product records 38
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Nevirapine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Nevirapine is a key part of combination HIV-1 treatment and can be highly effective when used correctly alongside other antiretroviral drugs. Its most serious risks — liver damage and severe skin reactions — are greatest in the first 18 weeks, so close medical monitoring during that period is essential. Never take it alone, never use it for post-exposure prophylaxis, and seek medical care immediately if you develop a rash, jaundice, or flu-like symptoms.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Nevirapine carries a serious FDA Boxed Warning for life-threatening liver damage and severe skin reactions. Severe, and sometimes fatal, liver failure has been reported — most often in the first 18 weeks of treatment. Women with higher immune cell counts (CD4+ counts above 250 cells/mm³), including pregnant women, are at the highest risk, but serious liver reactions can happen to anyone. Nevirapine must never be used for post-exposure prophylaxis (PEP) — fatal liver failure has occurred in people without HIV who took it for this purpose.

Serious and fatal skin reactions — including Stevens-Johnson syndrome and toxic epidermal necrolysis (large areas of skin breaking down) — have also occurred. Watch closely for any rash, especially in the first 6 weeks. If you develop a rash along with fever, fatigue, muscle aches, blistering, or yellowing of the skin or eyes, stop nevirapine immediately and seek emergency care. The first 18 weeks of therapy require intensive monitoring of liver function and skin. Do not restart nevirapine after any serious liver or skin reaction.

Read the full warning on DailyMed →

📖 Nevirapine: Patient Information Guide

A plain-language walkthrough of Nevirapine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Nevirapine is an antiviral ingredient used in combination with other HIV medicines to treat HIV-1 infection across several formulations.

  • Nevirapine immediate-release tablets: approved for adults and pediatric patients 15 days and older with HIV-1 infection, always in combination with other antiretroviral agents
  • Nevirapine extended-release tablets: approved for adults and for pediatric patients 6 years of age or older who have a body surface area (BSA) of 1.17 m² or greater, in combination with other antiretroviral agents
  • Nevirapine oral suspension: approved for adults and pediatric patients 15 days and older with HIV-1 infection, in combination with other antiretroviral agents
  • Not approved for post-exposure prophylaxis (PEP) — occupational or non-occupational — in any formulation
  • Therapy is not recommended to be initiated in adult women with CD4+ counts above 250 cells/mm³ or adult men with CD4+ counts above 400 cells/mm³ unless the benefits clearly outweigh the risks
⚙️How it works

Nevirapine belongs to a class called NNRTIs — non-nucleoside reverse transcriptase inhibitors. HIV needs an enzyme called reverse transcriptase to convert its genetic material and make copies of itself inside the body. Nevirapine binds directly to this enzyme and disrupts its active site, stopping it from working. Unlike some HIV drugs, it does not compete with the building blocks the virus uses — it physically deforms the enzyme so it cannot function.

Importantly, nevirapine does not work against HIV-2 and does not affect human DNA-copying enzymes. However, resistance can develop quickly if nevirapine is used alone or added as the only new drug to a failing treatment regimen — it must always be part of a full combination HIV regimen.

💊How it's taken

All nevirapine formulations are taken by mouth and always in combination with other HIV medicines. A mandatory 14-day lead-in period at a once-daily lower dose is required before advancing to the full dosing schedule — this step significantly reduces the risk of rash and must not be skipped. If dosing is interrupted for more than 7 days, the lead-in must be restarted.

  • Extended-release tablets: taken once daily, with or without food; must be swallowed whole — do not chew, crush, or divide
  • Immediate-release tablets and oral suspension: once daily during the lead-in period, then twice daily thereafter; the suspension should be shaken gently before use and the full measured dose administered with an oral syringe
  • If rash persists through the lead-in period, do not advance to the full dose — and if lead-in dosing reaches 28 days without resolution, an alternative regimen should be sought
🤒Side effects — in detail

The most common side effect is rash, which usually appears in the first 6 weeks; it is often mild but can sometimes be severe.

  • Rash (most common; ranges from mild to potentially life-threatening)
  • Headache
  • Diarrhea
  • Nausea
  • Fatigue
  • Abdominal pain
  • Joint pain (arthralgia)
  • Fever
  • Elevated liver enzymes on blood tests (sometimes without symptoms)

Serious reactions requiring immediate medical attention include signs of liver damage (yellowing skin or eyes, dark urine, upper stomach pain) and severe skin reactions (blistering, skin peeling, sores in the mouth, or rash with fever or organ symptoms). Do not wait — stop the medication and seek care right away if any of these develop.

⚠️Warnings & precautions
  • Liver damage (hepatotoxicity): Severe and fatal liver failure has been reported. The risk is highest in the first 18 weeks — and especially the first 6 weeks. Women with CD4+ counts above 250 cells/mm³ face the highest risk, but liver injury can occur in anyone. Liver enzymes must be monitored at baseline, before dose escalation, and regularly throughout treatment. Nevirapine must be permanently stopped if clinical hepatitis or liver enzyme elevations combined with rash or other symptoms occur — and must never be restarted.
  • Severe skin reactions: Stevens-Johnson syndrome and toxic epidermal necrolysis — both serious, potentially fatal conditions — have been reported, mostly in the first 6 weeks. Any rash during the lead-in period should pause dose escalation. Rash with systemic symptoms (fever, blistering, organ signs) requires immediate discontinuation.
  • Resistance: Nevirapine must never be used as the only HIV drug or added alone to a failing regimen — resistance develops rapidly under those conditions.
  • Immune reconstitution syndrome: When the immune system begins recovering after starting HIV therapy, it can overreact to previously hidden infections, causing new inflammation. Report any new or worsening symptoms to your doctor.
  • Fat redistribution: Changes in body fat distribution (including fat accumulation around the midsection or back of the neck, or fat loss from the face or limbs) have been reported with antiretroviral therapy.
🔀What it interacts with

Nevirapine is processed by liver enzymes (CYP3A and CYP2B6) and actively speeds up those same enzymes — which means it can lower the blood levels of many other drugs taken at the same time. Always tell your doctor and pharmacist about everything you take.

  • St. John's Wort: Can sharply reduce nevirapine levels, risking treatment failure and viral resistance — avoid entirely
  • Rifampin (TB antibiotic): Lowers nevirapine levels significantly; these drugs should not be used together — rifabutin may be an alternative
  • Ketoconazole / itraconazole (antifungals): Nevirapine reduces their levels to potentially ineffective concentrations — do not combine
  • Atazanavir (HIV protease inhibitor): Nevirapine substantially lowers atazanavir exposure — combination is not recommended
  • Efavirenz (NNRTI): Combining two NNRTIs increases side effects without benefit — not recommended
  • Methadone: Nevirapine can lower methadone levels enough to trigger withdrawal symptoms — dose monitoring and adjustment may be needed
  • Warfarin (blood thinner): Interaction is complex; nevirapine may raise or lower warfarin levels — anticoagulation must be monitored closely
  • Oral contraceptives: Nevirapine lowers hormone levels; use an additional or alternative form of birth control
  • Fluconazole (antifungal): Can raise nevirapine levels, increasing the risk of nevirapine side effects — use with caution and monitor closely
  • Calcium channel blockers, immunosuppressants, certain antiarrhythmics: Nevirapine may lower their levels — discuss with your doctor

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Moderate or severe liver disease (Child-Pugh Class B or C): Nevirapine is contraindicated — do not use
  • Post-exposure prophylaxis (PEP): Nevirapine must not be used for PEP — fatal liver failure has occurred in people without HIV who took it for this purpose
  • High CD4+ cell counts: Women with CD4+ counts above 250 cells/mm³ and men above 400 cells/mm³ face significantly higher risk of serious liver reactions — carefully weigh benefits and risks with your doctor
  • Hepatitis B or C co-infection: Increases risk of serious liver events — requires extra monitoring
  • Pregnancy: Nevirapine crosses the placenta. Available data from a pregnancy registry do not show an increase in major birth defects, but all pregnant women taking nevirapine should be enrolled in the Antiretroviral Pregnancy Registry (1-800-258-4263)
  • Breastfeeding: Women with HIV-1 should not breastfeed — both to avoid transmitting the virus and because nevirapine passes into breast milk
  • Children: The oral suspension and immediate-release tablet are approved for infants 15 days and older. The extended-release tablet is approved for children 6 years and older who meet the minimum body surface area requirement and can swallow tablets whole
  • Kidney disease / dialysis: Patients with mild to severe kidney impairment do not generally need a dose adjustment, but patients on dialysis require an additional dose after each dialysis session
  • Liver fibrosis or cirrhosis: Higher nevirapine blood levels have been observed — monitor carefully for signs of drug toxicity
🚑If you take too much

There is no antidote for a nevirapine overdose. Reported cases of excessive dosing have involved symptoms such as swelling, rash, fatigue, fever, headache, nausea, vomiting, dizziness, and weight loss. These symptoms resolved after nevirapine was stopped. If you suspect an overdose, contact a poison control center or emergency services immediately.

📡Pharmacodynamics — effects in the body

Nevirapine directly inhibits HIV-1 reverse transcriptase — the enzyme the virus uses to replicate — by binding to and disrupting its active site. This stops the virus from making copies of itself. Nevirapine does not inhibit HIV-2 reverse transcriptase or human DNA polymerase enzymes, meaning its antiviral action is specific to HIV-1. Resistance to nevirapine can emerge rapidly when it is used without other effective antiretrovirals, because HIV can mutate at the binding site.

🔬Pharmacokinetics — how your body processes it

Nevirapine is well absorbed when taken by mouth and is widely distributed throughout the body, including into the cerebrospinal fluid (the fluid around the brain and spinal cord) and across the placenta. It is broken down primarily in the liver through enzymes known as CYP3A and CYP2B6, and the breakdown products are mostly excreted in the urine. Importantly, nevirapine speeds up its own metabolism over time — a process called autoinduction — which causes its half-life (how long it stays in the body) to shorten from roughly 45 hours after the first dose to about 25–30 hours after several weeks of use, and increases how quickly it is cleared.

The extended-release tablet is absorbed more slowly, reaching peak blood levels around 24 hours after a dose, and can be taken with or without food without a meaningful difference in absorption. Patients on dialysis lose a significant portion of nevirapine during the dialysis session and require a supplemental dose afterward.

📦How to store it

Dispense in tight container as defined in the USP/NF. Store between 20º to 25°C (68°F to 77°F); excursions permitted to 15°to 30°C (59° to 86°F). Store in a safe place out of the reach of children.

📄 Written from Nevirapine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

180

Supplements & herbs that interact with Nevirapine

180 supplements and herbal products have documented interactions with Nevirapine 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 · 137
  • Minor · 37
Every supplement checked against Nevirapine — ranked by severity The full interaction hub: 6 major · 137 moderate · 37 minor · every one linked to its full report. Check Nevirapine 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.

🩺 Pharmacist Counseling Corner

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

What exactly is nevirapine and why do I need to take it with other HIV medicines?
Nevirapine is an antiviral drug that belongs to a class called NNRTIs — it works by blocking a key enzyme HIV needs to copy itself. But HIV is clever: if you only take one drug, the virus can mutate around it and become resistant very quickly. Taking nevirapine as part of a combination of HIV medicines hits the virus in multiple ways at once, making it much harder for it to develop resistance and keeping it suppressed.
Why do I have to start at a lower dose for the first two weeks?
That first 14-day period at a once-daily lower dose is called the lead-in period, and it's actually really important — it's been shown to significantly reduce the chance of developing a rash. Think of it as letting your body get used to the medication gradually. If you develop a rash during those two weeks, don't advance to the higher dose until it clears up, and tell your doctor right away. Never skip this step, and if you miss more than 7 days of doses, you'll need to start the lead-in all over again.
What side effects should I just monitor, and which ones should send me straight to the doctor?
Mild rash, headache, nausea, diarrhea, and fatigue are common and worth mentioning at your next visit, but the ones that require immediate action are signs of serious liver trouble — like yellowing of your skin or the whites of your eyes, dark urine, or stomach pain — or a severe skin reaction, like widespread blistering or skin peeling, or any rash that comes with fever, muscle aches, or feeling very unwell. Those are stop-the-medication-and-go-now situations. The first 18 weeks are the highest-risk window, so stay in close contact with your care team during that time.
Are there common medications or supplements I need to avoid while taking nevirapine?
Yes — this is really important. St. John's Wort, a popular herbal supplement, can drop nevirapine levels so much that the drug stops working and your virus could develop resistance — avoid it completely. Rifampin, used for tuberculosis, has the same problem. Certain antifungals like ketoconazole and itraconazole, some HIV drugs like atazanavir, and even standard birth control pills can all have significant interactions. If you take methadone, warfarin, or many other medications, your doses may need to be adjusted. Always give every doctor and pharmacist your full medication list before starting nevirapine.
Is it safe to take nevirapine during pregnancy?
Nevirapine does cross the placenta, so your baby is exposed to it. Data from a pregnancy registry haven't shown an increased risk of major birth defects compared to the general population. That said, pregnant women with higher CD4+ cell counts face a higher risk of the serious liver side effects that nevirapine can cause, so your doctor will monitor you very closely. If you're pregnant and taking nevirapine, your healthcare provider is encouraged to enroll you in the Antiretroviral Pregnancy Registry so outcomes can be tracked. And regardless, do not breastfeed — HIV can be transmitted through breast milk.
Can my child take nevirapine, and which form is right for them?
Yes, nevirapine is approved for children, but the right formulation depends on their age and size. The oral suspension and immediate-release tablet are approved for babies as young as 15 days old. The extended-release tablet is approved for children 6 years and older who are large enough — based on their body surface area — and who can swallow a tablet whole without chewing or crushing it. Your child's doctor will calculate the right dose based on their size, and the same 14-day lead-in period applies to kids as it does to adults.
Is Nevirapine available over the counter?
Nevirapine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Nevirapine first available?
Nevirapine has been available in the United States since at least 1996, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Nevirapine?
Nevirapine is supplied by 13 manufacturers listed in the FDA NDC Directory, including Aurobindo Pharma Limited, Mylan Pharmaceuticals Inc., Macleods Pharmaceuticals Limited.

💬 Answers drafted from Nevirapine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Nevirapine comes

Nevirapine 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.

Tablet

By mouth
Available strengths 1 strength
15 FDA-listed product records

Extended-release tablet

By mouth
Brands Viramune
Available strengths 2 strengths
9 FDA-listed product records

Oral suspension

By mouth
Brands Viramune
Available strengths 1 strength
3 FDA-listed product records

📊 Nevirapine across the U.S. market

How Nevirapine 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.

3
Dose forms
13
Manufacturers
2
Brand names
38
FDA-listed product records
1996
First marketed

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

Aurobindo Pharma Limited29%
Mylan Pharmaceuticals Inc.16%
Macleods Pharmaceuticals Limited13%
Amneal Pharmaceuticals LLC8%
Cipla Ltd.5%
Hetero Labs Limited5%
Other makers24%

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

📈 How widely Nevirapine is used

A general measure of how commonly Nevirapine 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 Nevirapine 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.

1,003
Medicaid prescriptions filled (Q1–Q4 2025)
$98,929 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Nevirapine prescribed? Of the 1,596 medications we measure, Nevirapine ranks #1,282 by Medicaid prescriptions — more than 20% of them.

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

Utilization by Nevirapine 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 10 mg/mL oral suspension is the most-dispensed Nevirapine product — about 47% of these Medicaid prescriptions.

nevirapine 10 MG/ML Oral Suspension Most dispensed

471 Medicaid prescriptions (Q1–Q4 2025) 47% of Nevirapine prescriptions shown $43,663 gross reimbursement (before rebates) ≈ $93 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 311943

24 HR nevirapine 400 MG Extended Release Oral Tablet

449 Medicaid prescriptions (Q1–Q4 2025) 45% of Nevirapine prescriptions shown $53,635 gross reimbursement (before rebates) ≈ $119 per prescription (gross)

Summed across the 1 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1095712

nevirapine 200 MG Oral Tablet

83 Medicaid prescriptions (Q1–Q4 2025) 8% of Nevirapine prescriptions shown $1,631 gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 2 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199422

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 Nevirapine, 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 4 of 35 listed Nevirapine NDCs with Medicaid activity.

🔍 Compare Nevirapine products

A representative set of FDA-listed product records for Nevirapine — 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.)

Showing 38 of 38 products — FDA National Drug Code Directory. See every product, package size and price: browse all 38 Nevirapine NDCs →

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) Nevirapine RxCUI 53654 3 dose forms · 4 strengths
  1. Dose form (SCDF) Extended Release Oral Tablet RxCUI 1095711 In current FDA listings
    Clinical drug / strength (SCD) 24 HR nevirapine 100 MG RxCUI 1373745 24 HR nevirapine 400 MG RxCUI 1095712
  2. Dose form (SCDF) Oral Suspension RxCUI 374595 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 311943
  3. Dose form (SCDF) Oral Tablet RxCUI 373046 In current FDA listings
    Clinical drug / strength (SCD) 200 MG RxCUI 199422

Look up RxCUI 53654 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.

🏷️ Sold under these brand names

Viramune Viramune XR

🏭 Manufacturers & labelers

Aurobindo Pharma Limited 11 Mylan Pharmaceuticals Inc. 6 Macleods Pharmaceuticals Limited 5 Amneal Pharmaceuticals LLC 3 Cipla Ltd. 2 Hetero Labs Limited 2 Micro Labs Limited 2 Zhejiang Huahai Pharmaceutical Co., Ltd. 2 Boehringer Ingelheim Pharmaceuticals Inc. 1 Boehringer Ingelheim Pharmaceuticals, Inc. 1 Camber Pharmaceuticals, Inc. 1 Strides Pharma Science Limited 1 Vijayasri Organics Private Limited 1

RxNorm drug class

Nevirapine 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 2B6 Inducers, Cytochrome P450 3A Inducers

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.

🔬 Where this comes from

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 Oct 15, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nevirapine.
📈
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 Nevirapine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
9
NDC products indexed
38
Distinct labelers/manufacturers represented
13
Linked representative label
Mylan Pharmaceuticals Inc.
Linked label effective
Oct 15, 2024
Composite sections available
23
Linked SPL Set ID
690da74b-2481-47fc-93ae-8340e0caf0a4
Linked SPL Document ID
750bda83-d972-44e2-85ae-26676e1e7c34
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 9 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.