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Prescription medicine · generic available

Lacosamide

Brand names: Vimpat, Motpoly XR

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
7Recalls (FDA reports)
58Companies
2008First FDA approval on file

Quick answers

What is Lacosamide used for?
The FDA-approved label (Vimpat, UCB, Inc., May 12, 2026) says: “VIMPAT is indicated for: Treatment of partial-onset seizures in patients 1 month of age and older Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older 1.1 Partial-Onset Seizures VIMPAT is indicated for the treatment of partial-onset seizures in patients 1 month 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 Lacosamide have a boxed warning?
No. None of the 68 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Lacosamide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Lacosamide been recalled?
FDA enforcement reports list 7 recalls of products of this medicine; the newest started June 4, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Lacosamide?
58 companies list prescription products of Lacosamide in the FDA NDC Directory, including Major Pharmaceuticals, Camber Pharmaceuticals, Inc. and Remedyrepack Inc..

What Lacosamide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

VIMPAT is indicated for: Treatment of partial-onset seizures in patients 1 month of age and older Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older 1.1 Partial-Onset Seizures VIMPAT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. …

— FDA label: Vimpat, UCB, Inc., effective May 12, 2026. Read the full label on DailyMed →

The FDA has 68 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 68 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Solution · Tablet · Injection · Injection, solution · Capsule, extended release
RouteOral · Intravenous
Prescription products164 in the FDA NDC Directory
Brand namesVimpat, Motpoly 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.

NADAC per unit for Lacosamide, by strength and form
Strength and formGeneric or brandPharmacies pay
lacosamide 10 mg/mL
solution		 Generic $0.0831 per mL
lacosamide 10 mg/mL
solution		 Brand: Vimpat $2.30 per mL
lacosamide 100 mg
capsule, extended release		 Brand: Motpoly XR $21.43 per capsule
lacosamide 100 mg
tablet		 Generic $0.1887 per tablet
lacosamide 100 mg
tablet, film coated		 Generic $0.1887 per tablet
lacosamide 100 mg
tablet, film coated		 Brand: Vimpat $18.53 per tablet
lacosamide 150 mg
capsule, extended release		 Brand: Motpoly XR $21.50 per capsule
lacosamide 150 mg
tablet		 Generic $0.2285 per tablet
lacosamide 150 mg
tablet, film coated		 Generic $0.2285 per tablet
lacosamide 150 mg
tablet, film coated		 Brand: Vimpat $19.65 per tablet
lacosamide 200 mg
capsule, extended release		 Brand: Motpoly XR $21.51 per capsule
lacosamide 200 mg
tablet		 Generic $0.2518 per tablet
lacosamide 200 mg
tablet, film coated		 Generic $0.2518 per tablet
lacosamide 200 mg
tablet, film coated		 Brand: Vimpat $19.63 per tablet
lacosamide 200 mg/20 mL
solution		 Generic $0.0831 per mL
lacosamide 50 mg
tablet		 Generic $0.1205 per tablet
lacosamide 50 mg
tablet, film coated		 Generic $0.1205 per tablet
lacosamide 50 mg
tablet, film coated		 Brand: Vimpat $11.83 per tablet

NADAC list of November 4, 2026; these prices took effect between July 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.

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.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA022253
VIMPAT		 Ucb IncOctober 28, 2008 34, latest October 16, 2023
2023: Labeling · 2023: Efficacy · 2022: Labeling
NDA022254
VIMPAT		 Ucb IncOctober 28, 2008 30, latest October 16, 2023
2023: Labeling · 2023: Efficacy · 2022: Labeling
NDA022255
VIMPAT		 Ucb IncApril 20, 2010 27, latest October 16, 2023
2023: Labeling · 2023: Efficacy · 2022: Labeling
NDA216185
MOTPOLY XR		 AuctaMay 4, 2023 1, latest June 7, 2024
2024: Efficacy

Generic approvals (34)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. June 4, 2026 · Class II · Ongoing · D-0626-2026

    Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.

    Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60. — Annora Pharma Private Limited

  2. March 13, 2025 · Class II · Ongoing · D-0330-2025

    CGMP Deviations

    Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC — Glenmark Pharmaceuticals Inc., USA

  3. March 13, 2025 · Class II · Ongoing · D-0321-2025

    CGMP Deviations

    Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# — Glenmark Pharmaceuticals Inc., USA

  4. March 13, 2025 · Class II · Ongoing · D-0337-2025

    CGMP Deviations

    Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# — Glenmark Pharmaceuticals Inc., USA

  5. March 13, 2025 · Class II · Ongoing · D-0343-2025

    CGMP Deviations

    Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 6 — Glenmark Pharmaceuticals Inc., USA

  6. December 6, 2022 · Class III · Terminated · D-0094-2023

    Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

    Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, — Camber Pharmaceuticals, Inc

  7. March 15, 2021 · Class II · Terminated · D-0590-2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35 — Cardinal Health Inc.

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

RxCUI (RxNorm)809974, 809984, 809987, 809990, 809992, 809994, 809996, 809998, 810000, 810002 … (+8)
SPL set ID of the quoted label9e79b42c-38a3-4b2c-a196-a5a1948250e2
FDA labels (SPL)68
FDA applicationsNDA022253, NDA022254, NDA022255, NDA216185, 34 ANDA
Active ingredients (FDA)LACOSAMIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Vimpat, UCB, Inc., effective May 12, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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