FDA-filed SPL labeling · retrieved through openFDA

Peginterferon Alfa-2a Injection

Peginterferon alfa-2a injection (Pegasys) is an antiviral medication used to treat chronic hepatitis C and chronic hepatitis B in eligible adults and children.

Brand name Pegasys
Drug class Interferon Alpha
Rx Form 1 Route Subcutaneous
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 1 clinical label set 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 effectiveSep 2, 2026
AvailabilityRx
Earliest approval/marketing year 2002
FDA-listed product records 14
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Peginterferon Alfa-2a Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Pegasys (peginterferon alfa-2a) is a once-weekly injectable antiviral that helps the immune system fight chronic hepatitis B and chronic hepatitis C. It is a powerful medication that requires close medical supervision because of serious potential risks, including severe depression, bone marrow suppression, and immune system complications. Always take it exactly as prescribed, attend all follow-up appointments, and report any new or worsening symptoms to your doctor right away.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Pegasys can cause serious — sometimes life-threatening — problems affecting the mind, immune system, blood vessels, and ability to fight infection. These include severe depression, suicidal thoughts, psychotic episodes, autoimmune disorders (where the immune system attacks the body), reduced blood flow to vital organs, and dangerous infections. These risks apply to all patients taking Pegasys. Your doctor will monitor you closely throughout treatment with regular check-ups and lab tests. If symptoms become severe or keep getting worse — such as deep depression, signs of infection, or unusual bleeding — Pegasys may need to be stopped. In many cases, these problems improve after the medication is discontinued.

Read the full warning on DailyMed →

📖 Peginterferon Alfa-2a Injection: Patient Information Guide

A plain-language walkthrough of Peginterferon Alfa-2a Injection — 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

Peginterferon alfa-2a injection (brand name Pegasys) is an antiviral agent approved for two major conditions:

  • Chronic hepatitis C (CHC) in adults: Pegasys is used in combination with other hepatitis C antiviral drugs for adults with compensated liver disease. Pegasys monotherapy is only appropriate when other HCV drugs cannot be tolerated or are contraindicated. It is also approved for adults with CHC co-infected with HIV.
  • Chronic hepatitis C in children (age 5–17): Pegasys is used in combination with ribavirin for pediatric patients 5 years and older with compensated liver disease.
  • Chronic hepatitis B (CHB) in adults: Pegasys treats both HBeAg-positive and HBeAg-negative CHB in adults with compensated liver disease, evidence of viral replication, and liver inflammation.
  • Chronic hepatitis B in children (age 3–17): Pegasys is approved for HBeAg-positive CHB in non-cirrhotic children 3 years of age and older with evidence of viral replication and elevated liver enzymes (ALT).
  • Limitations: Pegasys alone or with ribavirin (without additional HCV antiviral drugs) is not recommended for patients who previously failed interferon-alfa therapy, and is not recommended after solid organ transplantation.
⚙️How it works

Pegasys works by activating the body's innate antiviral immune response — the built-in system the body uses to recognize and fight viruses. It binds to the human type 1 interferon receptor on cell surfaces, causing those receptors to pair up (dimerize) and trigger a signaling cascade inside the cell. This leads to the production of antiviral proteins that block the hepatitis virus from replicating and spreading further. The "pegylated" part of the drug means it has been chemically attached to a molecule called polyethylene glycol, which slows its clearance from the body and allows once-weekly dosing instead of the more frequent dosing required by older interferon drugs.

💊How it's taken

Pegasys is given as a subcutaneous injection (a small shot under the skin) once a week, into the abdomen or thigh. There is no food restriction — it can be taken with or without meals. Treatment duration depends on whether you have hepatitis C or B, the specific virus genotype, your age, and which other drugs are being used alongside Pegasys. Children receive a dose adjusted to their body surface area. If you develop certain side effects — such as low blood counts or significant depression — your doctor may lower the dose or temporarily pause treatment.

  • Inject subcutaneously (under the skin) once weekly in the abdomen or thigh
  • Duration of treatment varies — follow your prescriber's plan exactly
  • Do not adjust your dose or stop treatment without talking to your doctor first
🤒Side effects — in detail

Most people experience at least one side effect with Pegasys; the most common ones feel similar to a bad flu, especially early in treatment:

  • Fatigue or weakness
  • Fever
  • Muscle aches
  • Headache
  • Chills (rigors)
  • Nausea or vomiting
  • Diarrhea or stomach pain
  • Depression, irritability, or trouble sleeping
  • Hair thinning (alopecia)
  • Injection site reactions

More serious reactions — including severe depression or suicidal thoughts, dangerous drops in blood counts, serious infections, vision changes, heart problems, or severe skin reactions — require prompt medical attention. Contact your doctor right away if any of these develop.

⚠️Warnings & precautions
  • Serious mental health risks: Pegasys can cause or worsen depression, suicidal thinking, psychosis, aggression, and drug relapse — in patients with or without prior psychiatric history. All patients must be monitored closely throughout treatment.
  • Bone marrow suppression: Pegasys lowers white blood cell and platelet counts, increasing infection and bleeding risk. Regular blood tests are required.
  • Autoimmune disorders: Pegasys can trigger conditions such as lupus, rheumatoid arthritis, thyroiditis, and inflammatory kidney disease.
  • Heart and blood vessel risks: High blood pressure, irregular heart rhythms, chest pain, heart attack, and stroke-like cerebrovascular events have been reported.
  • Liver risks: Patients with cirrhosis are at risk of hepatic decompensation (liver failure). Hepatitis B patients may experience temporary but severe hepatitis flares (ALT spikes) during or after treatment.
  • Lung complications: Serious lung problems, including pneumonia, pulmonary hypertension, and respiratory failure, can occur.
  • Eye problems: Vision loss, retinal damage, and optic nerve inflammation have been reported — a baseline eye exam is required for all patients.
  • Growth effects in children: Weight and height gain may slow during treatment in pediatric patients; most children catch up after treatment ends, but long-term data are limited.
  • Pregnancy: Pegasys can harm the fetus. When used with ribavirin, both partners must use two effective forms of contraception during treatment and for at least 6 months afterward. Ribavirin is strictly contraindicated in pregnancy.
🔀What it interacts with

Pegasys can affect the levels of other drugs in your body and vice versa. Key interactions to know about:

  • Theophylline (used for asthma or lung disease): Pegasys inhibits the liver enzyme (CYP1A2) that breaks down theophylline, raising blood levels by about 25% — monitoring and possible dose adjustments are needed.
  • Methadone: Pegasys can raise methadone blood levels by 10–15%; watch for signs of toxicity such as extreme drowsiness, slow or shallow breathing, or confusion.
  • Zidovudine (an HIV drug, AZT): combining with Pegasys and/or ribavirin significantly increases the risk of severe low white blood cell counts and anemia.
  • Other HIV antiretrovirals (NRTIs): patients on certain HIV drugs alongside Pegasys/ribavirin face a higher risk of serious liver decompensation — very close monitoring is required.
  • Azathioprine (an immune suppressant): combined use with pegylated interferon and ribavirin has caused severe pancytopenia (dangerous drops in all blood cell types) — this combination should be avoided.

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
  • Known allergy to alpha interferons or any component of Pegasys: do not take it — this is a contraindication.
  • Autoimmune hepatitis or severe liver failure (hepatic decompensation): Pegasys is contraindicated in these conditions.
  • Neonates and infants: Pegasys contains benzyl alcohol and must NOT be used in newborns or infants — it can cause serious and potentially fatal neurological complications.
  • Pregnancy: Tell your doctor if you are pregnant or planning to become pregnant. Pegasys can harm a fetus, and when combined with ribavirin, contraception is mandatory for both partners during treatment and for at least 6 months after.
  • Breastfeeding: Discuss risks with your doctor; the effects on a nursing infant are not fully known. Mothers co-infected with HIV should not breastfeed.
  • History of depression or psychiatric illness: Pegasys can worsen mental health conditions — use with extreme caution and inform your doctor of any history.
  • Heart disease: Tell your doctor about any existing heart conditions; Pegasys should be used with caution, especially if you also take ribavirin due to ribavirin-related anemia.
  • Kidney disease: Pegasys dose must be reduced in patients with severe kidney impairment (creatinine clearance below 30 mL/min); careful monitoring is needed for any degree of kidney disease.
  • Older adults: Side effects involving the nervous system, heart, and flu-like symptoms may be more severe in elderly patients; kidney function should be monitored.
  • Diabetes, thyroid disease, or other endocrine conditions: Pegasys can worsen or trigger these — tell your doctor if they are not well-controlled before starting.
🚑If you take too much

There is limited experience with Pegasys overdose. The highest recorded dose in any patient was 7 times the intended amount taken daily for 7 days, and no life-threatening reactions were attributed to it directly. Symptoms of too much Pegasys can include severe fatigue, elevated liver enzymes, and dangerously low blood counts (neutropenia and thrombocytopenia). There is no specific antidote, and dialysis does not effectively remove the drug — contact a poison control center or emergency services immediately if overdose is suspected.

📡Pharmacodynamics — effects in the body

Pegasys stimulates cells to produce antiviral effector proteins — including serum neopterin and 2',5'-oligoadenylate synthetase — that interfere with the hepatitis virus's ability to replicate inside the body. These proteins are measurable markers that confirm the drug is activating the immune pathway as intended. This immune activation is what drives both the antiviral benefit and many of the side effects (such as fever and fatigue) that patients experience during treatment.

🔬Pharmacokinetics — how your body processes it

After a subcutaneous injection, peak blood levels of Pegasys are reached roughly 3 to 4 days (72–96 hours) after the dose. The drug has a very long half-life — averaging about 160 hours (nearly 7 days) — which is why once-weekly dosing works. Steady-state blood levels build up over 5 to 8 weeks of weekly dosing in adults (about 12 weeks in children). Pegasys is cleared much more slowly than older, non-pegylated interferon alfa-2a, which is what makes it more convenient and more consistently active. In patients with severe kidney disease, clearance is reduced and the dose must be lowered; older adults and children also process the drug differently, requiring careful monitoring.

📦How to store it

Store in the refrigerator at 2°C to 8°C (36°F to 46°F). refrigerator for more than 24 hours. Do not freeze or shake.

📄 Written from Peginterferon Alfa-2a Injection’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 →

17

Supplements & herbs that interact with Peginterferon Alfa-2a Injection

17 supplements and herbal products have documented interactions with Peginterferon Alfa-2a Injection 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 · 7
  • Minor · 9
Every supplement checked against Peginterferon Alfa-2a Injection — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Peginterferon Alfa-2a Injection 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 Peginterferon Alfa-2a Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Pegasys and why did my doctor prescribe it for hepatitis?
Pegasys is a man-made version of a protein your immune system naturally produces called interferon. It essentially boosts your body's own antiviral defenses to help fight the hepatitis B or C virus. Your doctor prescribed it because you have chronic hepatitis — a long-term liver infection — and Pegasys, often combined with other antiviral drugs, is one of the treatments shown to help control or clear the virus in eligible patients.
How do I take this medication? Do I have to inject it myself?
Yes, Pegasys is given as a small injection under the skin — subcutaneously — once a week, into your abdomen or thigh. Your healthcare team will train you (or a family member) on how to do it correctly. It comes as a prefilled syringe or a vial, so you or your caregiver can give it at home. There's no special food requirement — you don't need to time it around meals. Try to give it on the same day each week to keep levels consistent.
The flu-like symptoms are really rough. Is that normal and will they get better?
Yes, unfortunately flu-like symptoms — fatigue, fever, chills, headache, and muscle aches — are among the most common side effects and many people find the first few weeks the hardest. These tend to be most noticeable in the first day or two after each injection and can improve as your body adjusts over time. Talk to your doctor about strategies to manage these symptoms — they won't just leave you struggling through it.
Should I be worried about depression while I'm on this medication?
This is one of the most important things to watch for with Pegasys. The medication can cause or worsen depression, irritability, and in serious cases, thoughts of self-harm — even in people who have never had mental health issues before. Please tell your doctor right away if you notice a low mood, hopelessness, withdrawal from others, or any thoughts of hurting yourself. Your doctor can adjust the dose or, if needed, stop the medication and get you support. Don't try to push through serious psychiatric symptoms on your own.
Can I use Pegasys if I'm pregnant or trying to get pregnant?
Pregnancy must be avoided while on Pegasys, especially if you're also taking ribavirin — that combination is strictly contraindicated because ribavirin causes serious birth defects and fetal death. Even Pegasys alone may harm a developing baby. If you can become pregnant, you'll need to use two effective forms of contraception during treatment and for at least 6 months after your last dose. Monthly pregnancy tests are required. Talk to your doctor about the safest plan for your situation before starting treatment.
What other medications or health conditions do I need to tell my doctor about before starting?
It's really important to give your doctor a complete picture. Key things to mention include: any history of depression or other mental health conditions; heart disease or irregular heartbeat; thyroid or diabetes issues; kidney disease; autoimmune conditions like lupus or rheumatoid arthritis; and all medications you take — especially theophylline, methadone, HIV drugs, or azathioprine, since Pegasys can raise levels of some of these or increase serious side effects. Your doctor needs this information to monitor you safely and adjust your treatment plan if needed.
Is Peginterferon Alfa-2a Injection available over the counter?
Peginterferon Alfa-2a Injection 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 Peginterferon Alfa-2a Injection first available?
Peginterferon Alfa-2a Injection has been available in the United States since at least 2002, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Peginterferon Alfa-2a Injection?
Peginterferon Alfa-2a Injection is supplied by 3 manufacturers listed in the FDA NDC Directory, including pharmaand GmbH, Genentech, Inc., zr pharma& GmbH.

💬 Answers drafted from Peginterferon Alfa-2a Injection’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 Peginterferon Alfa-2a Injection comes

Peginterferon Alfa-2a Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Under the skin
Brands Pegasys
How this form is used
What it may be used for
  • Pegasys subcutaneous injection is used to treat chronic hepatitis C (CHC) in adults with compensated liver disease, usually in combination with other HCV antiviral drugs
  • Pegasys subcutaneous injection is used to treat CHC in children 5 years and older in combination with ribavirin
  • Pegasys subcutaneous injection is used to treat chronic hepatitis B (CHB) in adults with compensated liver disease and evidence of active viral replication and liver inflammation
  • Pegasys subcutaneous injection is used to treat HBeAg-positive CHB in non-cirrhotic children 3 years of age and older
Important instructions
  • Pegasys is injected subcutaneously (just under the skin) once weekly into the abdomen or thigh
  • Pegasys dose and treatment duration vary depending on the condition, hepatitis virus genotype, patient age, and whether it is used with other antiviral drugs — always follow your prescriber's instructions
  • Pegasys dose may need to be reduced if you develop low blood counts, depression, elevated liver enzymes, or if you have significant kidney impairment — do not adjust the dose on your own
  • Pegasys is available as a vial and as a prefilled syringe — follow the administration instructions provided with whichever presentation you are given
Available strengths 2 strengths
14 FDA-listed product records

📊 Peginterferon Alfa-2a Injection across the U.S. market

How Peginterferon Alfa-2a Injection 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.

1
Dose forms
3
Manufacturers
1
Brand names
14
FDA-listed product records
2002
First marketed
pharmaand GmbH43%
Genentech, Inc.29%
zr pharma& GmbH29%

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

📈 How widely Peginterferon Alfa-2a Injection is used

A general measure of how commonly Peginterferon Alfa-2a Injection 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 Peginterferon Alfa-2a Injection 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.

431
Medicaid prescriptions filled (Q1–Q4 2025)
$1.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Peginterferon Alfa-2a Injection prescribed? Of the 1,596 medications we measure, Peginterferon Alfa-2a Injection ranks #1,377 by Medicaid prescriptions — more than 14% of them.

Where Peginterferon Alfa-2a Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Peginterferon Alfa-2a Injection 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.

Other Peginterferon Alfa-2a Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

431 Medicaid prescriptions (Q1–Q4 2025) 100% of Peginterferon Alfa-2a Injection prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $3,278 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity.

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 Peginterferon Alfa-2a Injection, 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 2 of 4 listed Peginterferon Alfa-2a Injection NDCs with Medicaid activity.

🔍 Compare Peginterferon Alfa-2a Injection products

A representative set of FDA-listed product records for Peginterferon Alfa-2a Injection — 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
💊Injection
180 mcg/0.5 mL Subcutaneous Genentech, Inc. × 2 listings BLA View NDC →
180 mcg/mL Subcutaneous Genentech, Inc. × 2 listings BLA View NDC →
180 mcg/0.5 mL Subcutaneous pharmaand GmbH × 3 listings BLA View NDC →
180 mcg/mL Subcutaneous pharmaand GmbH × 3 listings BLA View NDC →
180 mcg/0.5 mL Subcutaneous zr pharma& GmbH × 2 listings BLA View NDC →
180 mcg/mL Subcutaneous zr pharma& GmbH × 2 listings BLA View NDC →

Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Peginterferon Alfa-2a Injection 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) Peginterferon Alfa-2a Injection RxCUI 120608 3 dose forms · 3 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 378926 In current FDA listings
    Clinical drug / strength (SCD) 0.36 MG/ML RxCUI 403986
  2. Dose form (SCDF) Injection RxCUI 1651307 In current FDA listings
    Clinical drug / strength (SCD) 1 ML peginterferon alfa-2a 0.18 MG/ML RxCUI 351270
  3. Dose form (SCDF) Prefilled Syringe RxCUI 731325 No current FDA listing
    Clinical drug / strength (SCD) 0.5 ML peginterferon alfa-2a 0.36 MG/ML RxCUI 731326

Look up RxCUI 120608 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

Pegasys

🏭 Manufacturers & labelers

pharmaand GmbH 6 Genentech, Inc. 4 zr pharma& GmbH 4

RxNorm drug class

Peginterferon Alfa-2a Injection belongs to the Interferon alpha class.

Pharmacologic class Interferon alpha
Drug family (ATC) Interferons

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 Sep 2, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Peginterferon Alfa-2a Injection.
📈
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 Peginterferon Alfa-2a Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
14
Distinct labelers/manufacturers represented
3
Linked representative label
pharmaand GmbH
Linked label effective
Sep 2, 2026
Composite sections available
25
Linked SPL Set ID
d9290e5b-6d40-2318-e053-2995a90a9916
Linked SPL Document ID
5a83b298-9093-a93c-e063-6294a90a54aa
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set 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.

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. pharmaand GmbH 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.