Quick answers
- What is Oxcarbazepine used for?
- The FDA-approved label (Oxcarbazepine, Umedica Laboratories USA Inc., October 23, 2026) says: “Oxcarbazepine tablets is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine tablets is indicated for: Adults …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oxcarbazepine have a boxed warning?
- No. None of the 69 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Oxcarbazepine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oxcarbazepine been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started December 1, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Oxcarbazepine?
- 45 companies list prescription products of Oxcarbazepine in the FDA NDC Directory, including Remedyrepack Inc., Bryant Ranch Prepack and Breckenridge Pharmaceutical, Inc..
What Oxcarbazepine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Oxcarbazepine tablets is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine tablets is indicated for: Adults …
— FDA label: Oxcarbazepine, Umedica Laboratories USA Inc., effective October 23, 2026. Read the full label on DailyMed →
The FDA has 69 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 69 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Suspension · Tablet · Tablet, extended release · Tablet, film coated, extended release · For suspension |
|---|---|
| Route | Oral |
| Prescription products | 129 in the FDA NDC Directory |
| Brand names | Trileptal, Oxtellar XR |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| oxcarbazepine 150 mg tablet | Generic | $0.1067 per tablet |
| oxcarbazepine 150 mg tablet | Brand: Oxtellar XR | $9.03 per tablet |
| oxcarbazepine 150 mg tablet, extended release | Generic | $3.41 per tablet |
| oxcarbazepine 150 mg tablet, film coated | Generic | $0.1067 per tablet |
| oxcarbazepine 150 mg tablet, film coated | Brand: Trileptal | $5.72 per tablet |
| oxcarbazepine 300 mg tablet | Generic | $0.1714 per tablet |
| oxcarbazepine 300 mg tablet | Brand: Oxtellar XR | $12.75 per tablet |
| oxcarbazepine 300 mg tablet, extended release | Generic | $4.91 per tablet |
| oxcarbazepine 300 mg tablet, film coated | Generic | $0.1714 per tablet |
| oxcarbazepine 300 mg tablet, film coated | Brand: Trileptal | $10.45 per tablet |
| oxcarbazepine 300 mg/5 mL suspension | Generic | $0.1158 per mL |
| oxcarbazepine 60 mg/mL suspension | Generic | $0.1158 per mL |
| oxcarbazepine 60 mg/mL suspension | Brand: Trileptal | $1.93 per mL |
| oxcarbazepine 600 mg tablet | Generic | $0.3180 per tablet |
| oxcarbazepine 600 mg tablet | Brand: Oxtellar XR | $23.31 per tablet |
| oxcarbazepine 600 mg tablet, extended release | Generic | $9.38 per tablet |
| oxcarbazepine 600 mg tablet, film coated | Generic | $0.3180 per tablet |
| oxcarbazepine 600 mg tablet, film coated | Brand: Trileptal | $19.33 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 7, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Remedyrepack Inc.13 products
- Bryant Ranch Prepack8 products
- Breckenridge Pharmaceutical, Inc.6 products
- Major Pharmaceuticals6 products
- Coupler LLC5 products
- Novartis Pharmaceuticals Corporation4 products
- Cardinal Health 107, LLC4 products
- Advagen Pharma Ltd4 products
- Camber Pharmaceuticals, Inc.4 products
- NorthStar RxLLC3 products
- Advagen Pharma Limited3 products
- Supernus Pharmaceuticals, Inc.3 products
- Aurobindo Pharma Limited3 products
- Apotex Corp.3 products
- Zydus Lifesciences Limited3 products
- XLCare Pharmaceuticals, Inc.3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Ingenus Pharmaceuticals, LLC3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- Golden State Medical Supply, Inc.3 products
- American Health Packaging3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Ajanta Pharma USA Inc.3 products
- Umedica Laboratories USA Inc.3 products
- AvPAK3 products
- Zameer Pharmaceuticals LLC3 products
- ANI Pharmaceuticals, Inc.3 products
- Proficient Rx LP2 products
- Asclemed USA, Inc.1 product
- Macleods Pharmaceuticals Limited1 product
- Epic Pharma, LLC1 product
- DirectRx1 product
- Precision Dose, Inc.1 product
- Preferred Pharmaceuticals Inc.1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- Bionpharma Inc.1 product
- Novadoz Pharmaceuticals LLC1 product
- Biocon Pharma Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Kanchan Healthcare Inc1 product
- Marlex Pharmaceuticals, Inc.1 product
- Ascend Laboratories, LLC1 product
- Chartwell RX, LLC1 product
- Direct_Rx1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021014 TRILEPTAL | Novartis | January 14, 2000 | 34, latest September 23, 2025 2025: Labeling · 2024: Labeling · 2019: Labeling |
| NDA021285 TRILEPTAL | Novartis | May 25, 2001 | 26, latest September 23, 2025 2025: Labeling · 2024: Labeling · 2019: Labeling |
| NDA202810 OXTELLAR XR | Supernus Pharms | October 19, 2012 | 9, latest August 14, 2024 2024: Labeling · 2023: Labeling · 2018: Efficacy |
Generic approvals (24)
- ANDA077794Sun Pharm Inds · October 9, 2007
- ANDA077802Glenmark Pharms Ltd · October 9, 2007
- ANDA078005Ani Pharms · December 11, 2007
- ANDA078069Breckenridge Pharm · January 11, 2008
- ANDA077747Rubicon Research · April 9, 2008
- ANDA202961Amneal Pharms · September 17, 2012
- ANDA212428Chartwell Rx · June 21, 2021
- ANDA215939Annora Pharma · January 11, 2022
- ANDA215726Rubicon Research · August 30, 2022
- ANDA209652Bionpharma · November 4, 2022
- ANDA215332Aucta · November 30, 2022
- ANDA211747Zydus · July 3, 2023
- ANDA213369Apotex · July 13, 2023
- ANDA216749Hetero Labs Ltd III · October 20, 2023
- ANDA217782Pharmazone · February 14, 2024
- ANDA217659Ajanta Pharma Ltd · February 22, 2024
- ANDA218278Biocon Pharma · March 1, 2024
- ANDA207717Rubicon Research · March 5, 2024
- ANDA213183Alkem Labs Ltd · March 18, 2024
- ANDA215796Riconpharma LLC · November 22, 2024
- ANDA219241Aurobindo Pharma Ltd · April 30, 2025
- ANDA207300Macleods Pharms · July 11, 2025
- ANDA218341Umedica Labs Pvt · April 29, 2026
- ANDA209020Msn · May 29, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 1, 2022 · Class II · Terminated · D-0085-2023
Presence of foreign substance
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, — SUN PHARMACEUTICAL INDUSTRIES INC
-
January 29, 2014 · Class II · Terminated · D-1081-2014
Failed Tablet Specifications: Broken Tablets Present.
Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaz — Caraco Pharmaceutical Laboratories Ltd.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Oxcarbazepine, Umedica Laboratories USA Inc., effective October 23, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →