Quick answers
- What is Eslicarbazepine acetate used for?
- The FDA-approved label (Aptiom, Sumitomo Pharma America, Inc., November 10, 2023) says: “APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Eslicarbazepine acetate have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Eslicarbazepine acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Eslicarbazepine acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Eslicarbazepine acetate?
- 10 companies list prescription products of Eslicarbazepine acetate in the FDA NDC Directory, including Camber Pharmaceuticals, Inc., Dr.Reddys Laboratories Inc and Aurobindo Pharma Limited.
What Eslicarbazepine acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
— FDA label: Aptiom, Sumitomo Pharma America, Inc., effective November 10, 2023. Read the full label on DailyMed →
The FDA has 7 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 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 40 in the FDA NDC Directory |
| Brand names | Aptiom |
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 |
|---|---|---|
| eslicarbazepine acetate 200 mg tablet | Generic | $1.77 per tablet |
| eslicarbazepine acetate 200 mg tablet | Brand: Aptiom | $44.24 per tablet |
| eslicarbazepine acetate 400 mg tablet | Generic | $1.67 per tablet |
| eslicarbazepine acetate 400 mg tablet | Brand: Aptiom | $44.01 per tablet |
| eslicarbazepine acetate 600 mg tablet | Generic | $1.62 per tablet |
| eslicarbazepine acetate 600 mg tablet | Brand: Aptiom | $44.43 per tablet |
| eslicarbazepine acetate 800 mg tablet | Generic | $1.52 per tablet |
| eslicarbazepine acetate 800 mg tablet | Brand: Aptiom | $44.08 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 1, 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.
- Camber Pharmaceuticals, Inc.4 products
- Dr.Reddys Laboratories Inc4 products
- Aurobindo Pharma Limited4 products
- Ascend Laboratories, LLC4 products
- Lupin Pharmaceuticals, Inc.4 products
- Apotex Corp.4 products
- Sumitomo Pharma America, Inc.4 products
- Torrent Pharmaceuticals Limited4 products
- Golden State Medical Supply, Inc.4 products
- Jubilant Cadista Pharmaceuticals Inc.4 products
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 |
|---|---|---|---|
| NDA022416 APTIOM | Sumitomo Pharma Am | November 8, 2013 | 8, latest June 20, 2024 2024: Manufacturing (CMC) · 2019: Efficacy · 2017: Efficacy |
Generic approvals (8)
- ANDA211238DR Reddys · June 29, 2021
- ANDA211186Hetero Labs Ltd V · August 3, 2023
- ANDA211199Alkem Labs Ltd · October 6, 2023
- ANDA211236Apotex · December 7, 2023
- ANDA211227Torrent · February 27, 2024
- ANDA211246Lupin · March 27, 2024
- ANDA211219Jubilant Generics · August 4, 2025
- ANDA216481Aurobindo Pharma · August 5, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aptiom, Sumitomo Pharma America, Inc., effective November 10, 2023; 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 →