FDA-filed SPL labeling · retrieved through openFDA

Oxcarbazepine

Oxcarbazepine is an antiseizure medicine used to treat partial-onset seizures in adults and children, available as tablets, extended-release tablets, and oral suspension.

Brand names Oxtellar XrTrileptalOxtellar
Drug class Anti-epileptic Agent
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 77 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 effectiveDec 16, 2025
Clinical labels in scope 77
AvailabilityRx
Earliest approval/marketing year 2000
FDA-listed product records 320
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Oxcarbazepine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Oxcarbazepine is a well-established antiseizure medicine used to treat partial-onset seizures in adults and children, available in several forms including immediate-release tablets, oral suspension, and extended-release tablets. It works well but requires monitoring — particularly for low sodium levels, mood changes, and serious skin reactions. Never stop it suddenly, and let your doctor know about all other medicines you take, especially hormonal birth control.

📖 Oxcarbazepine: Patient Information Guide

A plain-language walkthrough of Oxcarbazepine — 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

Oxcarbazepine is an antiseizure medicine approved to treat partial-onset seizures — seizures that begin in a specific area of the brain.

  • Oxcarbazepine tablets are approved for adults as monotherapy (used alone) or adjunctive therapy (added to other seizure medicines) for partial-onset seizures.
  • Oxcarbazepine tablets are approved for children aged 4–16 as monotherapy and for children aged 2–16 as adjunctive therapy for partial-onset seizures.
  • Trileptal (tablets and oral suspension) is approved for adults with partial-onset seizures as monotherapy or adjunctive therapy, and for children aged 4–16 as monotherapy and aged 2–16 as adjunctive therapy.
  • Oxcarbazepine oral suspension is approved for adults as monotherapy or adjunctive therapy, and for children aged 4–16 as monotherapy and aged 2–16 as adjunctive therapy for partial-onset seizures.
  • Oxcarbazepine extended-release tablets are approved for partial-onset seizures in patients 6 years of age and older.
  • Oxtellar XR (tablet) is approved for partial-onset seizures in patients 6 years of age and older.
⚙️How it works

Oxcarbazepine is rapidly converted in the body to an active compound called MHD (10-monohydroxy metabolite), which does most of the work. MHD blocks voltage-sensitive sodium channels — the electrical switches that nerve cells use to fire. By blocking these channels, it calms overactive nerve cells, stops them from firing repeatedly, and prevents a seizure from spreading through the brain. Additional effects on potassium and calcium channels may also contribute to its antiseizure action.

💊How it's taken

Oxcarbazepine comes in tablets, oral suspension, and extended-release tablets — all taken by mouth. Tablets and oral suspension are typically taken twice daily; the extended-release tablet is taken once daily. Tablets and oral suspension can be taken with or without food.

  • Do not stop taking oxcarbazepine suddenly — your doctor will reduce the dose gradually to avoid triggering dangerous seizures.
  • If your kidneys are not working well, your doctor will adjust your dose accordingly.
  • Follow your prescriber's instructions exactly; do not adjust the dose on your own.
🤒Side effects — in detail

The most common side effects of oxcarbazepine include:

  • Dizziness
  • Drowsiness or fatigue
  • Double vision (diplopia) or blurred vision
  • Nausea or vomiting
  • Headache
  • Unsteady walking or poor coordination (ataxia)
  • Involuntary eye movements (nystagmus)
  • Tremor

Serious reactions — including severe skin rashes, dangerous drops in blood sodium, signs of suicidal thoughts, or allergic reactions involving throat swelling — require immediate medical attention. Contact your doctor or go to the emergency room right away if these occur.

⚠️Warnings & precautions
  • Low sodium (hyponatremia): Oxcarbazepine can cause sodium levels to drop to dangerous lows, especially in the first 3 months. Watch for nausea, headache, confusion, or worsening seizures, and tell your doctor immediately.
  • Serious skin reactions: Stevens-Johnson syndrome and toxic epidermal necrolysis — rare but potentially life-threatening rashes — have been reported. Stop taking oxcarbazepine and seek care right away if you develop a severe or spreading rash, blistering, or skin peeling. People who carry the HLA-B*1502 gene variant (more common in some Asian populations) may be at higher risk.
  • Suicidal thoughts and behavior: All antiseizure medicines, including oxcarbazepine, slightly increase the risk of suicidal thinking. Notify your doctor right away about any new or worsening depression, mood changes, or thoughts of self-harm.
  • Severe allergic reactions (anaphylaxis/angioedema): Swelling of the face, throat, or tongue can be life-threatening. Seek emergency help immediately.
  • Do not stop suddenly: Abruptly stopping oxcarbazepine can cause prolonged dangerous seizures (status epilepticus). Always taper with your doctor's guidance.
  • Driving and machinery: Oxcarbazepine can impair coordination, concentration, and alertness — do not drive until you know how it affects you.
🔀What it interacts with

Oxcarbazepine can interact with several medications — always tell your prescriber and pharmacist everything you take.

  • Phenytoin: Oxcarbazepine can raise phenytoin blood levels, increasing the risk of phenytoin toxicity. Your doctor may need to lower the phenytoin dose.
  • Carbamazepine, phenytoin, phenobarbital, and rifampin: These drugs lower the level of oxcarbazepine's active form (MHD) in your blood by 25–49%, which could make oxcarbazepine less effective. Dose adjustments may be needed.
  • Hormonal contraceptives (birth control pills or implants): Oxcarbazepine reduces the effectiveness of contraceptives containing ethinylestradiol or levonorgestrel. Use an additional non-hormonal method of birth control.

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
  • Do not take oxcarbazepine if you have had an allergic reaction to oxcarbazepine, any of its ingredients, or eslicarbazepine acetate.
  • Tell your doctor if you have ever had an allergic reaction to carbamazepine — about 25–30% of those patients will also react to oxcarbazepine.
  • Tell your doctor if you have kidney problems; a dose reduction is needed if your kidneys are not functioning well.
  • People of Han Chinese, Thai, Filipino, Malaysian, Korean, or Indian ancestry should discuss genetic testing (HLA-B*1502) with their doctor before starting, due to a higher risk of serious skin reactions.
  • Tell your doctor if you are pregnant or trying to become pregnant. Animal studies showed fetal harm; do not stop oxcarbazepine without talking to your doctor, as uncontrolled seizures during pregnancy carry serious risks.
  • Oxcarbazepine and its active metabolite pass into breast milk. Discuss risks and benefits with your doctor.
  • Women of childbearing age using hormonal birth control should use additional or alternative non-hormonal contraception while taking oxcarbazepine.
  • Older adults build up higher blood levels of the drug due to reduced kidney function — closer monitoring, especially of sodium levels, is needed.
🚑If you take too much

Taking too much oxcarbazepine can cause nausea, vomiting, drowsiness, dizziness, tremor, low blood pressure, confusion, and in severe cases, coma or seizures. There is no specific antidote. If you suspect an overdose, call Poison Control (1-800-222-1222) or go to an emergency room immediately — treatment is supportive and focused on managing symptoms.

📡Pharmacodynamics — effects in the body

Oxcarbazepine and its active metabolite MHD have antiseizure effects demonstrated in animal models — protecting against electrically and chemically triggered seizures and reducing recurring focal seizures. Importantly, studies in animals showed no development of tolerance (meaning the medicine did not become less effective over time with repeated daily use).

🔬Pharmacokinetics — how your body processes it

After you take oxcarbazepine by mouth, it is almost completely absorbed and quickly converted by the liver into its active form, MHD, which is responsible for the antiseizure effect. The original oxcarbazepine molecule has a short half-life of about 2 hours, while MHD stays in the body longer with a half-life of about 9 hours. MHD is then processed further and eliminated mainly through the kidneys — over 95% of the drug leaves the body in the urine. In older adults and in young children (who clear MHD faster per pound of body weight), blood levels may differ significantly from those in other adults, so prescribers adjust doses accordingly.

📦How to store it

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) . Dispense in tight container (USP). Store TRILEPTAL oral suspension in the original container.

📄 Written from Oxcarbazepine’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 →

122

Supplements & herbs that interact with Oxcarbazepine

122 supplements and herbal products have documented interactions with Oxcarbazepine 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 · 7
  • Moderate · 99
  • Minor · 16
Every supplement checked against Oxcarbazepine — ranked by severity The full interaction hub: 7 major · 99 moderate · 16 minor · every one linked to its full report. Check Oxcarbazepine 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.

2

Nutrient depletion considerations

Oxcarbazepine has been associated with lower levels of 2 nutrients 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.

Evidence & significance mix
  • Higher significance · 1
  • Moderate · 1
See the full Oxcarbazepine 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.

🩺 Pharmacist Counseling Corner

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

What is oxcarbazepine actually used for?
Oxcarbazepine is used to treat partial-onset seizures — seizures that start in one part of the brain. It can be used on its own or together with other seizure medicines, depending on your situation and age. Your doctor chose it specifically for seizure control.
How should I take it — does it matter if I take it with food?
Good news: the tablets and oral suspension can be taken with or without food, so you don't need to plan around meals. The extended-release tablet is taken once a day, while the regular tablets and suspension are usually taken twice a day. Just stick to whatever schedule your doctor set, and try to take it at the same times each day.
What side effects should I actually expect, and which ones mean I should call my doctor?
The most common ones are dizziness, drowsiness, double vision, nausea, and unsteady walking — these often settle as your body adjusts. But call your doctor right away if you get a severe skin rash, swelling of your face or throat, signs of confusion or worsening seizures (which can be a sign of low sodium), or any thoughts of harming yourself. These are serious and need prompt attention.
Can I just stop taking it if I feel better or if the side effects bother me?
Please don't stop suddenly — this is really important. Stopping oxcarbazepine abruptly can trigger prolonged, dangerous seizures called status epilepticus. If you want to stop or feel side effects are unbearable, call your doctor and they'll taper the dose down safely over time.
Does this medication affect my birth control?
Yes, it can. Oxcarbazepine lowers the levels of certain hormones used in birth control pills and implants, which can make them less effective. If you use hormonal contraception containing ethinylestradiol or levonorgestrel, talk to your doctor about adding or switching to a non-hormonal method while you're on this medicine.
Is it safe to take during pregnancy?
This is an important conversation to have with your doctor before or as soon as you find out you're pregnant. Animal studies showed possible harm to the fetus, and seizure levels in your blood can change during pregnancy. That said, uncontrolled seizures during pregnancy carry real risks too. Your doctor will help you weigh the risks and benefits — and they may recommend enrolling in a pregnancy registry to help monitor outcomes.
Is Oxcarbazepine available over the counter?
Oxcarbazepine 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 Oxcarbazepine first available?
Oxcarbazepine has been available in the United States since at least 2000, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Oxcarbazepine?
Oxcarbazepine is supplied by 73 manufacturers listed in the FDA NDC Directory, including Remedyrepack Inc., Bryant Ranch Prepack, American Health Packaging.

💬 Answers drafted from Oxcarbazepine’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 Oxcarbazepine comes

Oxcarbazepine 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
Brands Oxtellar Xr Trileptal
How this form is used
What it may be used for
  • Oxcarbazepine tablets are approved for partial-onset seizures in adults as monotherapy or adjunctive therapy.
  • Oxcarbazepine tablets are approved for partial-onset seizures in children aged 4–16 as monotherapy and in children aged 2–16 as adjunctive therapy.
  • Trileptal tablets are approved for partial-onset seizures in adults as monotherapy or adjunctive therapy, and in children aged 4–16 as monotherapy and aged 2–16 as adjunctive therapy.
Important instructions
  • Oxcarbazepine tablets and Trileptal tablets can be taken with or without food.
  • Oxcarbazepine tablets are typically taken twice a day — follow your prescriber's specific schedule.
  • Do not stop Trileptal or oxcarbazepine tablets abruptly; the dose should be reduced gradually under your doctor's guidance.
Available strengths 3 strengths
243 FDA-listed product records

Oral suspension

By mouth
Brands Trileptal
How this form is used
What it may be used for
  • Trileptal oral suspension is approved for partial-onset seizures in adults as monotherapy or adjunctive therapy.
  • Trileptal oral suspension is approved for partial-onset seizures in children aged 4–16 as monotherapy and in children aged 2–16 as adjunctive therapy.
  • Oxcarbazepine oral suspension is approved for partial-onset seizures in adults as monotherapy or adjunctive therapy, and in children aged 4–16 as monotherapy and aged 2–16 as adjunctive therapy.
Important instructions
  • Trileptal and oxcarbazepine oral suspension can be taken with or without food.
  • Oxcarbazepine oral suspension is typically taken twice a day — follow your prescriber's specific schedule.
  • Shake the oral suspension well before each use and measure doses carefully with the provided measuring device.
Available strengths 2 strengths
39 FDA-listed product records

Extended-release tablet

By mouth
How this form is used
What it may be used for
  • Oxcarbazepine extended-release tablets are approved for partial-onset seizures in patients 6 years of age and older.
Important instructions
  • Oxcarbazepine extended-release tablets are taken once daily by mouth.
  • Follow your prescriber's instructions for Oxcarbazepine extended-release tablets and do not stop taking them suddenly.
Available strengths 3 strengths
9 FDA-listed product records

📊 Oxcarbazepine across the U.S. market

How Oxcarbazepine 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
73
Manufacturers
3
Brand names
320
FDA-listed product records
2000
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 (29) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Remedyrepack Inc.16%
Bryant Ranch Prepack7%
American Health Packaging6%
Cardinal Health 107, LLC5%
Novartis Pharmaceuticals Corporation4%
Breckenridge Pharmaceutical, Inc.4%
Other makers57%

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

📈 How widely Oxcarbazepine is used

A general measure of how commonly Oxcarbazepine 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 Oxcarbazepine 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.

1,703,259
Medicaid prescriptions filled (Q1–Q4 2025)
$157.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Oxcarbazepine prescribed? Of the 1,596 medications we measure, Oxcarbazepine ranks #127 by Medicaid prescriptions — more than 92% of them.

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

Utilization by Oxcarbazepine 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 300 mg oral tablet is the most-dispensed Oxcarbazepine product — about 39% of these Medicaid prescriptions.

oxcarbazepine 300 MG Oral Tablet Most dispensed

670,873 Medicaid prescriptions (Q1–Q4 2025) 39% of Oxcarbazepine prescriptions shown $17.3M gross reimbursement (before rebates) ≈ $26 per prescription (gross)

Summed across the 21 of 98 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312137

oxcarbazepine 150 MG Oral Tablet

396,104 Medicaid prescriptions (Q1–Q4 2025) 23% of Oxcarbazepine prescriptions shown $6.4M gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 13 of 73 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312136

oxcarbazepine 600 MG Oral Tablet

369,455 Medicaid prescriptions (Q1–Q4 2025) 22% of Oxcarbazepine prescriptions shown $19.3M gross reimbursement (before rebates) ≈ $52 per prescription (gross)

Summed across the 15 of 75 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312138

oxcarbazepine 60 MG/ML Oral Suspension

224,549 Medicaid prescriptions (Q1–Q4 2025) 13% of Oxcarbazepine prescriptions shown $61.8M gross reimbursement (before rebates) ≈ $275 per prescription (gross)

Summed across the 9 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 283536

24 HR oxcarbazepine 600 MG Extended Release Oral Tablet

27,552 Medicaid prescriptions (Q1–Q4 2025) 2% of Oxcarbazepine prescriptions shown $42.4M gross reimbursement (before rebates) ≈ $1,540 per prescription (gross)

Summed across the 4 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1365844

24 HR oxcarbazepine 300 MG Extended Release Oral Tablet

12,016 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxcarbazepine prescriptions shown $9.2M gross reimbursement (before rebates) ≈ $768 per prescription (gross)

Summed across the 4 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1365842

24 HR oxcarbazepine 150 MG Extended Release Oral Tablet

2,710 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxcarbazepine prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $410 per prescription (gross)

Summed across the 4 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1365653

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 Oxcarbazepine, 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 70 of 306 listed Oxcarbazepine NDCs with Medicaid activity.

🔍 Compare Oxcarbazepine products

A representative set of FDA-listed product records for Oxcarbazepine — 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 200 of 320 products — FDA National Drug Code Directory. See every product, package size and price: browse all 320 Oxcarbazepine 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) Oxcarbazepine RxCUI 32624 3 dose forms · 7 strengths
  1. Dose form (SCDF) Oral Suspension RxCUI 375197 In current FDA listings
    Clinical drug / strength (SCD) 60 MG/ML RxCUI 283536
  2. Dose form (SCDF) Oral Tablet RxCUI 373175 In current FDA listings
    Clinical drug / strength (SCD) 150 MG RxCUI 312136 300 MG RxCUI 312137 600 MG RxCUI 312138

Look up RxCUI 32624 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

Oxtellar Xr Trileptal Oxtellar

🏭 Manufacturers & labelers

Remedyrepack Inc. 47 Bryant Ranch Prepack 20 American Health Packaging 18 Cardinal Health 107, LLC 14 Novartis Pharmaceuticals Corporation 12 Breckenridge Pharmaceutical, Inc. 12 Major Pharmaceuticals 12 Sun Pharmaceutical Industries, Inc. 10 NCS HealthCare of KY, LLC dba Vangard Labs 10 Glenmark Pharmaceuticals Inc., USA 9 Golden State Medical Supply, Inc. 9 Supernus Pharmaceuticals, Inc. 9 Camber Pharmaceuticals, Inc. 8 AvPAK 8 Archimica S.p.A. 7 Advagen Pharma Limited 6 F.i.s. Fabbrica Italiana Sintetici S.p.a. 6 ANI Pharmaceuticals, Inc. 6 Coupler LLC 5 Preferred Pharmaceuticals Inc. 3 Taro Pharmaceuticals U.S.A., Inc. 3 XLCare Pharmaceuticals Inc. 3 Zydus Pharmaceuticals (USA) Inc. 3 Zameer Pharmaceuticals LLC 3

…and 16 more on the FDA NDC directory.

RxNorm drug class

Oxcarbazepine belongs to the Anti-epileptic Agent class.

Pharmacologic class Anti-epileptic Agent
Drug family (ATC) Carboxamide derivatives

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 Dec 16, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Oxcarbazepine.
📈
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 Oxcarbazepine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
77
NDC products indexed
320
Distinct labelers/manufacturers represented
73
Linked representative label
Novartis Pharmaceuticals Corporation
Linked label effective
Dec 16, 2025
Composite sections available
25
Linked SPL Set ID
4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b
Linked SPL Document ID
dcd739ce-e938-40e6-8912-ca4f34b49cf3
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 77 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. Novartis Pharmaceuticals Corporation 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.