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OXTELLAR XR OXCARBAZEPINE 300 mg Tablet, 100-count — NDC 17772-0122-01 package photo

OXTELLAR XR OXCARBAZEPINE 300 mg Tablet, 100-count

by Supernus Pharmaceuticals, Inc. · 100 TABLET in 1 BOTTLE (17772-122-01)
NDC 17772-0122-01
🏷️ FDA NDC (as labeled) 17772-122-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$12.75 NADAC Per package$1,274.78 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $12.33/unit — full pricing hub ↓
Also comes in: 5 tablets 17772-0122-10 7 tablets 17772-0122-07
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 17772-122-01
Product NDC 17772-122
11-digit billing NDC 17772012201
NCPDP billing unit EA — each (per item)
Application # NDA202810
SPL Set ID aa610e56-1d1d-11e1-8bc2-0800200c9a66
Established class (EPC) Anti-epileptic Agent
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-01-17
Route ORAL
Dosage form TABLET
Substance OXCARBAZEPINE
GCN Seq No 070191
GCN 33557
HICL code 011735
Ingredient (HICL) Oxcarbazepine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4B
Therapeutic class — specific (HIC3) Anticonvulsants
AHFS code 28:12.24.00
AHFS class Ion Channel Inhibition Agents
FDB label name OXTELLAR XR 300 MG TABLET
FDB brand name Oxtellar Xr
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 17772-122-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 17772-0122-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerSupernus Pharmaceuticals, Inc.
Application holderSUPERNUS PHARMACEUTICALS INC
FDA applicationNDA202810 (NDA)
Labeler code17772
First marketedJan 2013
Product typeHuman Prescription Drug
Portfolio9 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name OXTELLAR XR 300 MG TABLET Ingredient Oxcarbazepine
📖 What it is MedlinePlus · NLM

Oxcarbazepine (Trileptal) is used alone or in combination with other medications to control certain types of seizures in adults and children. Oxcarbazepine extended-release tablets (Oxtellar XR) are used in combination with other medications to control certain types of seizures in adults and children 6 years of age and older. Oxcarbazepine is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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...
  • What is oxcarbazepine actually used for?
  • 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 reg...
  • How should I take it — does it matter if I take it with food?
📖 Read our full Oxcarbazepine guide →
2
Nutrient depletion considerations

Oxcarbazepine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Oxcarbazepine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color brown / yellow / red
ShapeOval
Imprint600
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII HAF0412YIT
    Polyethylene glycol 2000 is a synthetic liquid polymer used as a solvent, humectant, and lubricant in medications. It helps dissolve active ingredients, retain moisture, and improve how the medicine flows during manufacturing.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

14 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $12.748 $1,274.78 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $12.33 $1,233.49 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Jan 2026 Apr 2026 Aug 2026 $12.755 $10.744
▲ Up 19% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxcarbazepine 300 mg 00904-7263-61 Major 1 tablet $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 50268-0680-15 AvPAK 1 tablet $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 72603-0271-01 NorthStar 100 tablets $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 72888-0088-01 Advagen 100 tablets $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 31722-0024-01 Camber 100 tablets $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 68462-0138-01 Glenmark 100 tablets $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 62559-0221-01 ANI 100 tablets $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 51991-0293-01 Breckenridge 100 tablets $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 72888-0460-01 Advagen 100 tablets $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 51991-0054-01 Breckenridge 100 tablets $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 60687-0722-01 American 1 tablet $0.164 AB Availability likely save 99%
Oxcarbazepine 300 mg 27241-0238-01 Ajanta 100 tablets $4.503 AB Availability likely save 65%
Oxcarbazepine 300 mg 50742-0612-01 Ingenus 100 tablets $4.503 AB Availability likely save 65%
Trileptal 300 mg 00078-0337-05 Novartis 100 tablets $10.456 AB Availability likely save 18%
Oxtellar Xr 300 mgthis 17772-0122-01 Supernus 100 tablets $12.748 AB Availability likely —
Oxcarbazepine 300 mg 60505-4129-05 Apotex 500 tablets — AB FDA listed —
Oxcarbazepine 300 mg 63629-9186-01 Bryant 500 tablets — AB FDA listed —
Oxcarbazepine 300 mg 72865-0284-01 XLCare 100 tablets — AB FDA listed —
Oxcarbazepine 300 mg 87063-0208-01 ASCLEMED 100 tablets — AB FDA listed —
Oxcarbazepine 300 mg 72162-1594-01 Bryant 100 tablets — AB FDA listed —
Oxcarbazepine 300 mg 70518-2370-00 REMEDYREPACK 1 tablet — AB Discontinued —
Oxcarbazepine 300 mg 00615-8448-39 NCS 30 tablets — AB Discontinued —
Oxcarbazepine 300 mg 60429-0062-01 Golden 100 tablets — AB FDA listed —
Oxcarbazepine 300 mg 67046-1640-03 Coupler 30 tablets — AB FDA listed —
oxcarbazepine 300 mg 68382-0692-01 Zydus 100 tablets — — FDA listed —
Oxcarbazepine 300 mg 70518-2276-00 REMEDYREPACK 30 tablets — AB FDA listed —
Oxcarbazepine 300 mg 70518-3237-02 REMEDYREPACK 30 tablets — AB FDA listed —
Oxcarbazepine 300 mg 00904-7594-61 Major 1 tablet — AB FDA listed —
Oxcarbazepine 300 mg 55154-4320-00 Cardinal 1 tablet — AB FDA listed —
oxcarbazepine 300 mg 70771-1843-00 Zydus 1000 tablets — — FDA listed —
Oxcarbazepine 300 mg 71335-2548-01 Bryant 30 tablets — AB FDA listed —
Oxcarbazepine 300 mg 62756-0184-08 Sun 100 tablets — AB FDA listed —
Oxcarbazepine 300 mg 67046-2084-03 Coupler 30 tablets — AB FDA listed —
Oxcarbazepine 300 mg 70518-4663-00 REMEDYREPACK 30 tablets — AB FDA listed —
Oxcarbazepine 300 mg 71335-0090-01 Bryant 30 tablets — AB FDA listed —
Oxcarbazepine 300 mg 55154-2138-00 Cardinal 1 tablet — AB FDA listed —
Oxcarbazepine 300 mg 60290-0068-01 Umedica 100 tablets — AB FDA listed —
Oxcarbazepine 300 mg 67046-0868-03 Coupler 30 tablets — AB FDA listed —
Oxcarbazepine 300 mg 82804-0209-72 Proficient 120 tablets — AB FDA listed —
Oxcarbazepine 300 mg 00615-8635-39 NCS 30 tablets — AB FDA listed —
Oxcarbazepine 300 mg 70518-3921-00 REMEDYREPACK 1 tablet — AB FDA listed —
Oxcarbazepine 300 mg 90096-0172-01 Zameer 100 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2012
First FDA approval
Oct 2012
📍
2026
Currently FDA-listed
14 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2027. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 19, 2012 AB TE-rated RLD RS ⏳ ~0.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10220042 — method of use (U-2501)
US 9119791 — method of use (U-2041)
US 7910131 — method of use (U-2041)
US 10220042 — method of use (U-2501)
US 7910131 — method of use (U-2041)
US 9119791 — method of use (U-2041)
US 9119791 — method of use (U-2041)
US 10220042 — method of use (U-2501)
US 7910131 — method of use (U-2041)
US 11896599 — drug product
US 11166960 — drug product
US 9855278 — drug product
US 9855278 — drug product
US 7722898 — drug product
US 7722898 — drug product
US 9370525 — drug product
US 9855278 — drug product
US 11166960 — drug product
US 8821930 — drug product
US 7722898 — drug product
US 9370525 — drug product
US 8821930 — drug product
US 8617600 — drug product
US 8821930 — drug product
US 9351975 — drug product
US 11166960 — drug product
US 8617600 — drug product
US 11896599 — drug product
US 8617600 — drug product
US 11896599 — drug product
US 9351975 — drug product
US 9370525 — drug product
US 9351975 — drug product
2012 2014 2016 2018 2020 2022 2024 2026
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (33)
PatentTypeUse codeExpires
US 10220042 ↗ Method of use U-2501 Apr 13, 2027
US 9119791 ↗ Method of use U-2041 Apr 13, 2027
US 7910131 ↗ Method of use U-2041 Apr 13, 2027
US 10220042 ↗ Method of use U-2501 Apr 13, 2027
US 7910131 ↗ Method of use U-2041 Apr 13, 2027
US 9119791 ↗ Method of use U-2041 Apr 13, 2027
US 9119791 ↗ Method of use U-2041 Apr 13, 2027
US 10220042 ↗ Method of use U-2501 Apr 13, 2027
US 7910131 ↗ Method of use U-2041 Apr 13, 2027
US 11896599 ↗ Drug product — Apr 13, 2027
US 11166960 ↗ Drug product — Apr 13, 2027
US 9855278 ↗ Drug product — Apr 13, 2027
US 9855278 ↗ Drug product — Apr 13, 2027
US 7722898 ↗ Drug product — Apr 13, 2027
US 7722898 ↗ Drug product — Apr 13, 2027
US 9370525 ↗ Drug product — Apr 13, 2027
US 9855278 ↗ Drug product — Apr 13, 2027
US 11166960 ↗ Drug product — Apr 13, 2027
US 8821930 ↗ Drug product — Apr 13, 2027
US 7722898 ↗ Drug product — Apr 13, 2027
US 9370525 ↗ Drug product — Apr 13, 2027
US 8821930 ↗ Drug product — Apr 13, 2027
US 8617600 ↗ Drug product — Apr 13, 2027
US 8821930 ↗ Drug product — Apr 13, 2027
US 9351975 ↗ Drug product — Apr 13, 2027
US 11166960 ↗ Drug product — Apr 13, 2027
US 8617600 ↗ Drug product — Apr 13, 2027
US 11896599 ↗ Drug product — Apr 13, 2027
US 8617600 ↗ Drug product — Apr 13, 2027
US 11896599 ↗ Drug product — Apr 13, 2027
US 9351975 ↗ Drug product — Apr 13, 2027
US 9370525 ↗ Drug product — Apr 13, 2027
US 9351975 ↗ Drug product — Apr 13, 2027
Common questions
Is there a generic version of OXTELLAR XR 300 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for OXTELLAR XR 300 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 17772-0122-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6.8K
Units reimbursed last 4 qtrs
507.9K
Gross reimbursed last 4 qtrs
$6.27M
Avg / prescription
$918.56
Avg / unit
$12.3349
Latest quarter Q4 2025
1.4KRx
Medicaid pays / ea
$12.3349
gross reimbursed
vs
NADAC / ea
$12.7478
acquisition cost
=
Spread
−$0.4129
-3% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
42% FFS 58% MCO
Fee-for-service · 2,854 Rx Managed care · 3,967 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,074 units · 77.0 per 100k residents ME Washington: 12,066 units · 154 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 2,062 units · 35.9 per 100k residents MN Wisconsin: 11,436 units · 194 per 100k residents WI Michigan: 9,193 units · 91.6 per 100k residents MI New York: 39,991 units · 204 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 2,045 units · 63.8 per 100k residents IA Illinois: 8,559 units · 68.2 per 100k residents IL Indiana: 31,651 units · 461 per 100k residents IN Ohio: 44,111 units · 374 per 100k residents OH Pennsylvania: 9,049 units · 69.8 per 100k residents PA New Jersey: 3,562 units · 38.3 per 100k residents NJ Massachusetts: 18,694 units · 267 per 100k residents MA California: 18,133 units · 46.5 per 100k residents CA Utah: 9,552 units · 280 per 100k residents UT Colorado: 13,493 units · 230 per 100k residents CO Nebraska: 510 units · 25.8 per 100k residents NE Missouri: 25,404 units · 410 per 100k residents MO Kentucky: 11,394 units · 252 per 100k residents KY West Virginia: no data reported WV Virginia: 9,399 units · 108 per 100k residents VA Maryland: no data reported MD Connecticut: 28,048 units · 775 per 100k residents CT Rhode Island: no data reported RI Arizona: 4,193 units · 56.4 per 100k residents AZ New Mexico: 4,820 units · 228 per 100k residents NM Kansas: 510 units · 17.3 per 100k residents KS Arkansas: 1,290 units · 42.1 per 100k residents AR Tennessee: 12,500 units · 175 per 100k residents TN North Carolina: 69,137 units · 638 per 100k residents NC South Carolina: 3,340 units · 62.2 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 5,145 units · 112 per 100k residents LA Mississippi: no data reported MS Alabama: 1,787 units · 35.0 per 100k residents AL Georgia: 8,258 units · 74.9 per 100k residents GA D.C.: no data reported DC Hawaii: 722 units · 50.3 per 100k residents HI Texas: 60,633 units · 199 per 100k residents TX Florida: 26,185 units · 116 per 100k residents FL
Units reimbursed · per 100k residents
17.3775
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 775 /100k
2 North Carolina 638 /100k
3 Indiana 461 /100k
4 Missouri 410 /100k
5 Ohio 374 /100k
6 Utah 280 /100k
7 Massachusetts 267 /100k
8 Kentucky 252 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page17772-0122-01 6,127 Rx · $5,808,263
5 tablets17772-0122-10 No Medicaid data
7 tablets17772-0122-07 No Medicaid data
Drug total (last 4 qtrs): 6,127 Rx · 463,252 units · $5,808,263 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Oxtellar XR — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Oxtellar XR. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.82M
Claims incl. refills
1.9K
Beneficiaries
772
Spend / beneficiary
$3,650.16
Spend / claim
$1,506.10
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for OXTELLAR XR (this brand).

Top reported reactions

Seizure1,430
Fatigue844
Somnolence783
Dizziness719
Hyponatraemia717
Headache703
Drug Interaction690

Age at onset

Neonate118
Infant77
Child269
Adolescent134
Adult1,229
Elderly304

Reporter sex

16,266 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization4,998
Death1,320
Life-threatening849
Disabling286
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,556 700
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
17772-0122-01 You're viewing this 100 TABLET in 1 BOTTLE (17772-122-01) $12.75 / ea $1,274.78 2013-01-17 Active
17772-0122-10 5 TABLET in 1 BLISTER PACK (17772-122-10) — — 2013-01-17 Active
17772-0122-07 7 TABLET in 1 BOTTLE (17772-122-07) — — 2023-07-01 Active

You're viewing the largest of 3 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 17772-0122-01?
NDC 17772-0122-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 17772-0122-01 and NDC 17772-0122-10?
Both are OXTELLAR XR OXCARBAZEPINE 300 mg Tablet — the drug itself is identical. NDC 17772-0122-01 is the 100-count package, while NDC 17772-0122-10 is the 5 tablets package.
What NDC number is used to bill for this package of OXTELLAR XR OXCARBAZEPINE 300 mg Tablet?
Bill NDC 17772-0122-01 — the 11-digit billing format is 17772012201. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 43 words ▾

1 INDICATIONS AND USAGE Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older. Oxtellar XR® is indicated for the treatment of partial-onset seizures in patients 6 years of age and older. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Adult Patients: The recommended initial dosage is 600 mg once per day. Increase the dosage in weekly increments of 600 mg once per day, based on clinical response and tolerability, to a recommended maintenance dosage of 1200 mg to 2400 mg once per day. ( 2.2 ) In adult patients with a creatinine clearance <30 mL/min, initiate at one-half the usual starting dosage and increase slowly.

( 2.3 ) Pediatric Patients: The recommended dosage is based on body weight and is administered orally once per day. Increase the dosage in weekly intervals based on clinical response and tolerability, to the recommended dosage. ( 2.2 ) Geriatric Patients: Start at lower dosage (300 mg or 450 mg/day) and increase slowly.

( 2.4 ) In conversion of oxcarbazepine immediate-release to Oxtellar XR ® , higher dosages of Oxtellar XR may be necessary. ( 2.7 , 12.3 )

2.1Important Administration Instructions Administer Oxtellar XR as a single daily dose taken on an empty stomach (at least 1 hour before or at least 2 hours after meals) [see Clinical Pharmacology (12.3) ] . If Oxtellar XR is taken with food, adverse reactions are more likely to occur because of increased peak levels [see Clinical Pharmacology (12.3) ]. Swallow Oxtellar XR tablets whole.

Do not cut, crush, or chew the tablets. For ease of swallowing in pediatric patients or patients with difficulty swallowing, achieve daily dosages with multiples of appropriate lower strength tablets (e.g., 150 mg tablets).

2.2General Dosing Recommendations Monotherapy or Adjunctive Therapy Adult Patients Initiate treatment at a dosage of 600 mg/day given orally once daily for one week. Subsequent dosage increases can be made at weekly intervals in 600 mg/day increments to achieve the recommended daily dosage. The recommended daily dosage of Oxtellar XR is 1200 mg to 2400 mg/day, given once daily.

The dosage of 2400 mg/day showed slightly greater efficacy than 1200 mg/day, but was associated with an increase in adverse reactions [see Adverse Reactions (6.1) and Clinical Studies (14.1) ]. Dosage adjustment is recommended with concomitant use of strong CYP3A4 enzyme inducers or UGT inducers, which include certain antiepileptic drugs (AEDs) [see Drug Interactions (7.1 , 7.2) ]. Pediatric Patients (6 to Less than 17 Years of Age) In pediatric patients 6 to less than 17 years of age, initiate treatment at a daily dosage of 8 mg/kg to 10 mg/kg orally once daily, not to exceed 600 mg per day in the first week.

Subsequent dosage increases can be made at weekly intervals in 8 mg/kg to 10 mg/kg increments once daily, not to exceed 600 mg, to achieve the target daily dosage. The target maintenance dosage, achieved over two to three weeks, is displayed in Table 1. Table 1: Target Daily Dosage in Pediatric Patients (6 to Less Than 17 Years of Age) Weight Target Daily Dosage 20 kg to 29 kg 900 mg/day 29.1 kg to 39 kg 1200 mg/day Greater than 39 kg 1800 mg/day Dosage adjustment is recommended with concomitant use of strong CYP3A4 enzyme inducers or UGT inducers, which include certain antiepileptic drugs (AEDs) [see Drug Interactions (7.1 , 7.2) )].

2.3Dosage Modifications in Adult Patients with Renal Impairment In adult patients with severe renal impairment (creatinine clearance less than 30 mL/minute), initiate Oxtellar XR at one-half the usual starting dosage (300 mg/day). Subsequent dosage increases can be made at weekly intervals in increments of 300 mg to 450 mg/day to achieve the desired clinical response [see Use in Specific Populations (8.6) ].

2.4Dosage Modifications in Geriatric Patients In geriatric patients, consider starting at a lower dosage (300 mg or 450 mg/day). Subsequent dosage increases can be made at weekly intervals in increments of 300 mg to 450 mg/day to achieve the desired clinical effect [see Use in Specific Populations (8.5) ].

2.5Dosage Modification with Concomitant Use of Strong CYP3A4 Enzyme Inducers or UGT Enzyme Inducers Strong CYP3A4 inducers, including enzyme-i…

💊 Dosage Forms and Strengths 53 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release tablets: 150 mg: yellow modified-oval shaped with "150" printed on one side 300 mg: brown modified-oval shaped with "300" printed on one side 600 mg: brownish red modified-oval shaped with "600" printed on one side Extended-release tablets: 150 mg, 300 mg and 600 mg ( 3 )

⛔ Contraindications 58 words ▾

4 CONTRAINDICATIONS Oxtellar XR is contraindicated in patients with a known hypersensitivity to oxcarbazepine, to any of the components of Oxtellar XR, or to eslicarbazepine acetate. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.2 , 5.3) ]. Known hypersensitivity to oxcarbazepine, any of the components of Oxtellar XR, or to eslicarbazepine acetate. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hyponatremia: Monitor sodium as recommended. ( 5.1 ) Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs. ( 5.3 ) Serious Dermatological Reactions: Discontinue if observed.

( 5.4 ) Suicidal Behavior and Ideation: Monitor for symptoms. ( 5.5 ) Withdrawal of Oxtellar XR ® : Withdrawal gradually. ( 5.6 ) Drug Reaction with Eosinophilia and Systemic symptoms (DRESS)/Multi-Organ Hypersensitivity: Discontinue if suspected.

( 5.7 ) Hematologic Reactions: Discontinue if suspected. ( 5.8 ) Risk of Seizure Aggravation: Discontinue if occurs. ( 5.10 )

5.1Hyponatremia Clinically significant hyponatremia (sodium <125 mmol/L) may develop during Oxtellar XR use. Serum sodium levels less than 125 mmol/L have occurred in immediate-release oxcarbazepine-treated patients generally in the first three months of treatment. However, clinically significant hyponatremia may develop more than a year after initiating therapy.

Most immediate-release oxcarbazepine-treated patients who developed hyponatremia were asymptomatic in clinical trials. However, some of these patients had their dosage reduced, discontinued, or had their fluid intake restricted for hyponatremia. Serum sodium levels returned toward normal when the dosage was reduced or discontinued, or when the patient was treated conservatively (e.g., fluid restriction).

Cases of symptomatic hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been reported during post-marketing use of immediate-release oxcarbazepine. Among treated patients in a controlled trial of adjunctive therapy with Oxtellar XR in 366 adults with complex partial seizures, 1 patient receiving 2400 mg experienced a severe reduction in serum sodium (117 mEq/L) requiring discontinuation from treatment, while 2 other patients receiving 1200 mg experienced serum sodium concentrations low enough (125 and 126 mEq/L) to require discontinuation from treatment.

The overall incidence of clinically significant hyponatremia in patients treated with Oxtellar XR was 1.2%, although slight shifts in serum sodium concentrations from Normal to Low (<135 mEq/L) were observed for the 2400 mg (6.5%) and 1200 mg (9.8%) groups compared to placebo (1.7%). Measure serum sodium concentrations if patients develop symptoms of hyponatremia (e.g., nausea, malaise, headache, lethargy, confusion, obtunded consciousness, or increase in seizure frequency or severity). Consider measurement of serum sodium concentrations during treatment with Oxtellar XR, particularly if the patient receives concomitant medications known to decrease serum sodium levels (for example, drugs associated with inappropriate ADH secretion).

5.2Anaphylactic Reactions and Angioedema Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of immediate-release oxcarbazepine. Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with Oxtellar XR, discontinue the drug and initiate an alternative treatment.

Do not rechallenge these patients with Oxtellar XR.

5.3Cross Hypersensitivity Reaction to Carbamazepine Approximately 25% to 30% of patients who have had hypersensitivity reactions to carbamazepine will experience hypersensitivity reactions with Oxtellar XR. For this reason, patients should be specifically questioned about any prior experience with carbamazepine, and patients with a history of hypersensitivity reactions to carbamazepine should ordinarily be treated with Oxtellar XR only if the potential benefit justifies the potential risk. Discontinue Oxtellar XR immediately if signs or symptoms of hypersensitivity develop [see Warnings and Precautions (5.2 , 5.7) ].

5.4Serious Dermatological Reactions Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TE…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described in other sections of the labeling: Hyponatremia [see Warnings and Precautions (5.1) ] Anaphylactic Reactions and Angioedema [see Warnings and Precautions (5.2) ] Cross Hypersensitivity Reaction to Carbamazepine [see Warnings and Precautions (5.3) ] Serious Dermatological Reactions [see Warnings and Precautions (5.4) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] Withdrawal of AEDs [see Warnings and Precautions (5.6) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions (5.7) ] Hematologic Reactions [see Warnings and Precautions (5.8) ] Risk of Seizures in the Pregnant Patient [see Warnings and Precautions (5.9) ] Most commonly observed (≥5% and more frequent than placebo) adverse reactions in adults were dizziness, somnolence, headache, balance disorder, tremor, vomiting, diplopia, asthenia, and fatigue.

( 6.1 ) Adverse reactions in pediatric patients are similar to those seen in adult patients. To report SUSPECTED ADVERSE REACTIONS, contact Supernus, Inc. at (1-866-398-0833) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data presented below are from 384 patients with partial-onset seizures who received Oxtellar XR (366 adults and 18 pediatric patients) with concomitant AEDs. In addition, safety data presented below are from a total of 2288 patients with seizure disorders treated with immediate-release oxcarbazepine; 1832 were adults and 456 were pediatric patients.

Most Common Adverse Reactions Reported by Adult Patients Receiving Concomitant AEDs in Oxtellar XR Clinical Studies Table 3 lists adverse reactions that occurred in at least 2% of adult patients with epilepsy treated with Oxtellar XR or placebo and concomitant AEDs and that were numerically more common in the patients treated with any dosage of Oxtellar XR than in patients receiving placebo. Table 3: Adverse Reaction Incidence in a Controlled Clinical Study of Oxtellar XR with Concomitant AEDs in Adults Reported by ≥ 2% of patients treated with Oxtellar XR and numerically more frequent than in the placebo group Oxtellar XR 2400 mg/day N=123 % Oxtellar XR 1200 mg/day N=122 % Placebo N=121 % Any System / Any Term 69 57 55 Nervous System Disorders Dizziness 41 20 15 Somnolence 14 12 9 Headache 15 8 7 Balance Disorder 7 5 5 Tremor 1 5 2 Nystagmus 3 3 1 Ataxia 1 3 1 Gastrointestinal Disorders Vomiting 15 6 9 Abdominal Pain Upper 0 3 1 Dyspepsia 0 3 1 Gastritis 0 3 2 Eye Disorders Diplopia 13 10 4 Vision Blurred 1 4 3 Visual Impairment 1 3 0 General Disorders and Administration Site Conditions Asthenia 7 3 1 Fatigue 3 6 1 Gait Disturbance 0 3 1 Drug Intolerance 2 0 0 Infections and Infestations Nasopharyngitis 0 3 0 Sinusitis 0 3 2 The overall incidence of adverse reactions appeared to be dose related, particularly during the titration period.

The most commonly observed (≥ 5%) adverse reactions seen in association with Oxtellar XR and more frequent than in placebo-treated patients were: dizziness, somnolence, headache, balance disorder, tremor, vomiting, diplopia, and asthenia. Adverse Reactions Associated with Discontinuation of Oxtellar XR Treatment: Approximately 23.3% of the 366 adult patients receiving Oxtellar XR in clinical studies discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation of Oxtellar XR (reported by ≥2%) were: dizziness (9.8%), vomiting (5.3%), nausea (3.7%), diplopia (3.2%), and somnolence (2.4%).

Adjunctive Therapy with Oxtellar XR in Pediatric Patients 6 to Less than 17 Years of Age Previously Tre…

🔄 Drug Interactions 206 words ▾

7 DRUG INTERACTIONS Phenytoin, Carbamazepine, and Phenobarbital: Coadministration decreased blood levels of an active metabolite of Oxtellar XR: Greater dosage of Oxtellar XR may be required. ( 2.5 , 7.2 ) Oral Contraceptives : Advise patients that Oxtellar XR may decrease the effectiveness of hormonal contraceptives. Additional non-hormonal forms of contraception are recommended. ( 7.3 )

7.1Effect of Oxtellar XR on Other Drugs It is recommended that the plasma levels of phenytoin be monitored during the period of Oxtellar XR titration and dosage modification [see Clinical Pharmacology (12.3) ]. A decrease in the dosage of phenytoin may be required.

7.2Effect of Other Drugs on Oxtellar XR If Oxtellar XR and strong CYP3A4 inducers or UGT inducers (e.g., rifampin, carbamazepine, phenytoin and phenobarbital) are administered concurrently, it is recommended that the plasma levels of MHD be monitored during the period of Oxtellar XR titration [see Clinical Pharmacology (12.3) ]. Dosage adjustment of Oxtellar XR may be required after initiation, dosage modification, or discontinuation of such inducers [see Dosage and Administration (2.5) ].

7.3Hormonal Contraceptives Concurrent use of immediate-release oxcarbazepine with hormonal contraceptives may render these contraceptives less effective [see Clinical Pharmacology (12.3) ]. Studies with other oral or implant contraceptives have not been conducted.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 5.9 , 8.1 ) Severe Hepatic Impairment: Not recommended. ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as Oxtellar XR, during pregnancy. Encourage women who are taking Oxtellar XR during pregnancy to enroll in the North American Antiepileptic Drug (NAAED Pregnancy Registry) by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of Oxtellar XR in pregnant women; however, Oxtellar XR is closely related structurally to carbamazepine, which is considered to be teratogenic in humans.

Data on a limited number of pregnancies from pregnancy registries suggest that oxcarbazepine monotherapy use is associated with congenital malformations (e.g., craniofacial defects such as oral clefts, and cardiac malformations such as ventricular septal defects). Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals treated with either oxcarbazepine or its active 10-hydroxy metabolite (MHD) during pregnancy at doses similar to the maximum recommended human dose (MRHD).

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations An increase in seizure frequency may occur during pregnancy because of altered levels of the active metabolite of oxcarbazepine.

Monitor patients carefully during pregnancy and through the postpartum period [see Warnings and Precautions (5.9) ] Data Human Data Data from published registries have reported craniofacial defects such as oral clefts and cardiac malformations such as ventricular septal defects in children with prenatal oxcarbazepine exposure. Animal Data When pregnant rats were given oxcarbazepine (30, 300, or 1000 mg/kg/day) orally throughout the period of organogenesis, increased incidences of fetal malformations (craniofacial, cardiovascular, and skeletal) and variations were observed at the intermediate and high doses (approximately 1.2 and 4 times, respectively, the MRHD on a mg/m 2 basis).

Increased embryofetal death and decreased fetal body weights were seen at the high dose. Doses ≥ 300 mg/kg were also maternally toxic (decreased body weight gain, clinical signs), but there is no evidence to suggest that teratogenicity was secondary to the maternal effects. In a study in which pregnant rabbits were orally administered MHD (20, 100, or 200 mg/kg/day) during organogenesis, embryofetal mortality was increased at the highest dose (1.5 times the MRHD on a mg/m 2 basis).

This dose produced only minimal maternal toxicity. In a study in which female rats were dosed orally with oxcarbazepine (25, 50, or 150 mg/kg/day) during the latter part of gestation and throughout the lactation period, a persistent reduction in body weights and altered behavior (decreased activity) were observed in offspring exposed to the highest dose (0.6 times the MRHD on a mg/m 2 basis). Oral administration of MHD (25, 75, or 250 mg/kg/day) to rats during gestation and lactation resulted in a persistent reduction in offspring weights at the highest dose (equivalent to the MRHD on a mg/m 2 basis).

8.2Lactation Risk Summary Oxcarbazepine and its active metabolite (MHD) are present in human milk after oxcarbazepine administration. The effects of oxcarbazepine and its active metabolite (MHD) on the breastfed infant or on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Oxtellar XR and any potential adverse effec…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as Oxtellar XR, during pregnancy. Encourage women who are taking Oxtellar XR during pregnancy to enroll in the North American Antiepileptic Drug (NAAED Pregnancy Registry) by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of Oxtellar XR in pregnant women; however, Oxtellar XR is closely related structurally to carbamazepine, which is considered to be teratogenic in humans.

Data on a limited number of pregnancies from pregnancy registries suggest that oxcarbazepine monotherapy use is associated with congenital malformations (e.g., craniofacial defects such as oral clefts, and cardiac malformations such as ventricular septal defects). Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals treated with either oxcarbazepine or its active 10-hydroxy metabolite (MHD) during pregnancy at doses similar to the maximum recommended human dose (MRHD).

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations An increase in seizure frequency may occur during pregnancy because of altered levels of the active metabolite of oxcarbazepine.

Monitor patients carefully during pregnancy and through the postpartum period [see Warnings and Precautions (5.9) ] Data Human Data Data from published registries have reported craniofacial defects such as oral clefts and cardiac malformations such as ventricular septal defects in children with prenatal oxcarbazepine exposure. Animal Data When pregnant rats were given oxcarbazepine (30, 300, or 1000 mg/kg/day) orally throughout the period of organogenesis, increased incidences of fetal malformations (craniofacial, cardiovascular, and skeletal) and variations were observed at the intermediate and high doses (approximately 1.2 and 4 times, respectively, the MRHD on a mg/m 2 basis).

Increased embryofetal death and decreased fetal body weights were seen at the high dose. Doses ≥ 300 mg/kg were also maternally toxic (decreased body weight gain, clinical signs), but there is no evidence to suggest that teratogenicity was secondary to the maternal effects. In a study in which pregnant rabbits were orally administered MHD (20, 100, or 200 mg/kg/day) during organogenesis, embryofetal mortality was increased at the highest dose (1.5 times the MRHD on a mg/m 2 basis).

This dose produced only minimal maternal toxicity. In a study in which female rats were dosed orally with oxcarbazepine (25, 50, or 150 mg/kg/day) during the latter part of gestation and throughout the lactation period, a persistent reduction in body weights and altered behavior (decreased activity) were observed in offspring exposed to the highest dose (0.6 times the MRHD on a mg/m 2 basis). Oral administration of MHD (25, 75, or 250 mg/kg/day) to rats during gestation and lactation resulted in a persistent reduction in offspring weights at the highest dose (equivalent to the MRHD on a mg/m 2 basis).

🧒 Pediatric Use 124 words ▾

8.4Pediatric Use The safety and effectiveness of Oxtellar XR in pediatric patients 6 years of age and older for the treatment of partial-onset seizures is supported by: An adequate and well-controlled safety and efficacy study of Oxtellar XR in adults that included pharmacokinetic sampling [see Clinical Studies (14.1) ], A pharmacokinetic study of Oxtellar XR in pediatric patients, which included patients 6 to less than 17 years of age [see Clinical Pharmacology (12.3) ], Safety and efficacy studies with the immediate-release formulation in adults and pediatric patients [see Clinical Studies (14.2) and Adverse Reactions (6.1) ] .

Oxtellar XR ® is not approved for pediatric patients less than 6 years of age because the size of the tablets are inappropriate for younger children.

🧓 Geriatric Use 101 words ▾

8.5Geriatric Use Following administration of single (300 mg) and multiple (600 mg/day) doses of immediate-release oxcarbazepine to elderly volunteers (60-82 years of age), the maximum plasma concentrations and AUC values of MHD were 30%-60% higher than in younger volunteers (18-32 years of age). Comparisons of creatinine clearance in young and elderly volunteers indicate that the difference was due to age-related reductions in creatinine clearance. Consider starting at a lower dosage and lower titration [see Dosage and Administration (2.4) ] .

Close monitoring of sodium levels is required in elderly patients at risk for hyponatremia [see Warnings and Precautions (5.1) ].

🆘 Overdosage 107 words ▾

10 OVERDOSAGE

10.1Human Overdose Experience Isolated cases of overdose with immediate-release oxcarbazepine have been reported. The maximum dose taken was approximately 48,000 mg. All patients recovered with symptomatic treatment.

Nausea, vomiting, somnolence, aggression, agitation, hypotension, and tremor each occurred in more than one patient. Coma, confusional state, convulsion, dyscoordination, depressed level of consciousness, diplopia, dizziness, dyskinesia, dyspnea, QT prolongation, headache, miosis, nystagmus, overdose, decreased urine output, and blurred vision also occurred.

10.2Treatment and Management There is no specific antidote for Oxtellar XR overdose. Administer symptomatic and supportive treatment as appropriate. Options include removal of the drug by gastric lavage and/or inactivation by administering activated charcoal.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The pharmacological activity of Oxtellar XR is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine [see Clinical Pharmacology (12.3) ]. The precise mechanism by which oxcarbazepine and MHD exert their antiseizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses.

These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.

12.2Pharmacodynamics Oxcarbazepine and its active metabolite (MHD) exhibit anticonvulsant properties in animal seizure models. They protected rodents against electrically induced tonic extension seizures and, to a lesser degree, chemically induced clonic seizures, and abolished or reduced the frequency of chronically recurring focal seizures in Rhesus monkeys with aluminum implants. No development of tolerance (i.e., attenuation of anticonvulsive activity) was observed in the maximal electroshock test when mice and rats were treated daily for five days and four weeks, respectively, with oxcarbazepine or MHD.

12.3Pharmacokinetics Following oral administration, oxcarbazepine is absorbed and extensively metabolized to its pharmacologically active 10-monohydroxy metabolite (MHD), which is responsible for most antiepileptic activity. In clinical studies of Oxtellar XR, the elimination half-life of oxcarbazepine was between 7 and 11 hours; the elimination half-life of MHD is between 9 and 11 hours. In a mass balance study in humans, only 2% of total radioactivity in plasma after administration of immediate-release oxcarbazepine was due to unchanged oxcarbazepine, with approximately 70% present as MHD, and the remainder attributable to minor metabolites.

Absorption Oxtellar XR administered as a once daily dosage is not bioequivalent to the same total dosage of the immediate-release formulation given twice daily at steady state. Steady state plasma concentrations of MHD are reached within 5 days when Oxtellar XR is given once daily. At steady state, when 1200 mg Oxtellar XR was given once daily, MHD C max occurred 7 hours post-dose.

At steady state, Oxtellar XR given once daily produced MHD exposures (AUC and C max ) about 19% lower and MHD minimum concentrations (C min ) about 16% lower than the immediate-release oxcarbazepine given twice daily when administered at the same 1200 mg total daily dosage. When Oxtellar XR was administered at an equivalent 600 mg single dose (4 × 150 mg tablets, 2 × 300 mg tablets, or 1 × 600 mg tablet), equivalent MHD exposures (AUC) were observed. Following a single dose of Oxtellar XR (1 × 150 mg tablets, 1 × 300 mg tablets, or 1 × 600 mg tablet), the pharmacokinetics of MHD are not linear and show greater than dose proportional increase in AUC and less than proportional increase in C max : AUC increases 2.4-fold and C max increases 1.9-fold with a 2-fold increase in dose.

Effect of Food: Single dose administration of 600 mg Oxtellar XR following a high fat meal (800 – 1000 calories) produced MHD exposure (AUC) equivalent to that produced under fasting conditions. Peak MHD concentration (C max ) was about 60% higher and occurred 2 hours earlier under fed conditions than under fasting conditions. The increase in C max , even without a significant change in the overall exposure, should be considered by the prescriber especially during the titration phase, when some adverse reactions are most likely to occur coincidentally with peak levels.

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🧬 Mechanism of Action 127 words ▾

12.1Mechanism of Action The pharmacological activity of Oxtellar XR is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine [see Clinical Pharmacology (12.3) ]. The precise mechanism by which oxcarbazepine and MHD exert their antiseizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses.

These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.

📦 How Supplied / Storage and Handling 105 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied 150 mg (yellow modified-oval shaped tablet printed "150" on one side with edible black ink). Bottles of 100 tablets NDC 17772-121-01 300 mg (brown modified-oval shaped tablet printed "300" on one side with edible black ink). Bottles of 100 tablets NDC 17772-122-01 600 mg (brownish red modified-oval shaped tablet printed "600" on one side with edible black ink). Bottles of 100 tablets NDC 17772-123-01

16.2Storage and Handling Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [See USP controlled room temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.

📦 Storage and Handling 33 words ▾

16.2Storage and Handling Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [See USP controlled room temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.

📋 Description 153 words ▾

11 DESCRIPTION Oxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is Oxcarbazepine is off-white to yellow crystalline powder.

Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is C 15 H 12 N 2 O 2 and its molecular weight is 252.27.

Oxtellar XR tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, yellow iron oxide (150 mg, 300 mg tablets only), red iron oxide (300 mg, 600 mg tablets only), black iron oxide (300 mg tablet only), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide. Each tablet is printed on one side with edible black ink. 1

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved patient labeling (Medication Guide). Administration Information Advise patients to take the tablet whole. Do not cut, chew, or crush the tablet.

Advise patients to take Oxtellar XR on an empty stomach. This means they should take Oxtellar XR at least one hour before food or at least two hours after food [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ] . Hyponatremia Advise patients that Oxtellar XR may reduce serum sodium concentrations especially if they are taking other medications that can lower sodium.

Advise patients to report symptoms of low sodium like nausea, tiredness, lack of energy, confusion, and more frequent or more severe seizures [see Warnings and Precautions (5.1) ]. Anaphylactic Reactions and Angioedema Anaphylactic reactions and angioedema may occur during treatment with Oxtellar XR. Advise patients to immediately report signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, tongue, or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their physician [see Warnings and Precautions (5.2) ].

Cross Hypersensitivity Reaction to Carbamazepine Inform patients who have exhibited hypersensitivity reactions to carbamazepine that approximately 25%-30% of these patients may also experience hypersensitivity reactions with Oxtellar XR. If patients experience a hypersensitivity reaction while taking Oxtellar XR, advise them to consult with their physician immediately [see Warnings and Precautions (5.3) ]. Serious Dermatological Reactions Advise patients that serious skin reactions have been reported in association with immediate-release oxcarbazepine.

If patients experience a skin reaction while taking Oxtellar XR, advise patients to consult with their physician immediately [see Warnings and Precautions (5.4) ]. Suicidal Behavior and Ideation Counsel patients, their caregivers, and families that AEDs, including Oxtellar XR, may increase the risk of suicidal thoughts and behavior and that they need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.

Advise them to immediately report behaviors of concern to healthcare providers [see Warnings and Precautions (5.5) ]. DRESS/Multi-Organ Hypersensitivity Instruct patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction, etc.) occurring during treatment with Oxtellar XR may be drug-related, and advise them to consult their physician immediately [see Warnings and Precautions (5.7) ]. Hematologic Reactions Advise patients that there have been rare reports of blood disorders reported in patients treated with immediate-release oxcarbazepine.

Instruct patients to immediately consult with their physician if they experience symptoms suggestive of blood disorders during treatment with Oxtellar XR [see Warnings and Precautions (5.8) ]. Drug Interactions Warn female patients of childbearing age that the concurrent use of Oxtellar XR with hormonal contraceptives may render this method of contraception less effective [see Drug Interactions (7.3) and Use in Specific Populations (8.1) ]. Additional non-hormonal forms of contraception are recommended when using Oxtellar XR.

Pregnancy Registry Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during OXTELLAR XR therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use in Specific Populations (8.1) ].

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 12/2018 MEDICATION GUIDE Oxtellar XR ® (ahks-TEH-lahr eks ahr) (oxcarbazepine) extended-release tablets, for oral use What is the most important information I should know about Oxtellar XR? Do not stop taking Oxtellar XR without first talking to your healthcare provider.

Stopping Oxtellar XR suddenly can cause serious problems. Oxtellar XR can cause serious side effects, including: Oxtellar XR may cause the level of sodium in your blood to be low. Symptoms of low blood sodium include: nausea tiredness, lack of energy headache confusion more frequent or more severe seizures Similar symptoms that are not related to low sodium may occur from taking Oxtellar XR.

You should tell your healthcare provider if you have any of these side effects and if they bother you or they do not go away. Some other medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking.

Your healthcare provider may do blood tests to check your sodium levels during your treatment with Oxtellar XR . Oxtellar XR may also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.

Call your healthcare provider right away if you have any of the following: swelling of your face, eyes, lips, or tongue trouble swallowing or breathing a skin rash hives fever, swollen glands, or sore throat that does not go away or comes and goes painful sores in the mouth or around your eyes yellowing of your skin or eyes unusual bruising or bleeding severe fatigue or weakness severe muscle pain frequent infections that do not go away Many people who are allergic to carbamazepine are also allergic to Oxtellar XR. Tell your healthcare provider if you are allergic to carbamazepine.

Like other antiepileptic drugs, Oxtellar XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop taking Oxtellar XR without first talking to a healthcare provider. Stopping Oxtellar XR suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. What is Oxtellar XR?

Oxtellar XR is a prescription medicine used to treat partial onset seizures in adults and children 6 years of age and older. Oxtellar XR is not for use in children under 6 years of age. It is not known if Oxtellar XR is safe and effective in children under 6 years of age.

Who should not take Oxtellar XR? Do not take Oxtellar XR if you are allergic to oxcarbazepine or any of the other ingredients in Oxtellar XR, or to eslicarbazepine acetate. See the end of this Medication Guide for a complete list of ingredients in Oxtellar XR.

What should I tell my healthcare provider before taking Oxtellar XR? Before taking Oxtellar XR…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.