Quick answers
- What is Lamotrigine used for?
- The FDA-approved label (Lamictal, GlaxoSmithKline LLC, October 10, 2025) says: “LAMICTAL is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: • partial-onset seizures. • primary generalized tonic-clonic (PGTC) seizures. • generalized seizures of Lennox-Gastaut syndrome. Epilepsy—monotherapy in patients aged 16 years and older …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lamotrigine have a boxed warning?
- Yes. The FDA label for Lamictal has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Lamotrigine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lamotrigine been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started July 20, 2022 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Lamotrigine?
- 46 companies list prescription products of Lamotrigine in the FDA NDC Directory, including GlaxoSmithKline LLC, Remedyrepack Inc. and Zydus Lifesciences Limited.
What Lamotrigine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LAMICTAL is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: • partial-onset seizures. • primary generalized tonic-clonic (PGTC) seizures. • generalized seizures of Lennox-Gastaut syndrome. Epilepsy—monotherapy in patients aged 16 years and older …
— FDA label: Lamictal, GlaxoSmithKline LLC, effective October 10, 2025. Read the full label on DailyMed →
The FDA has 103 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
101 of 103 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated, extended release · Tablet, orally disintegrating · Tablet, extended release · Tablet, chewable · Tablet, for suspension · Suspension |
|---|---|
| Route | Oral |
| Prescription products | 287 in the FDA NDC Directory |
| Brand names | Lamictal, Lamictal XR, Subvenite, Lamictal ODT |
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 |
|---|---|---|
| lamotrigine 10 mg/mL suspension | Brand: Subvenite | $2.86 per mL |
| lamotrigine 100 mg tablet | Generic | $0.0483–$1.59 per tablet 22 packages, lowest to highest |
| lamotrigine 100 mg tablet | Brand: Lamictal | $10.91 per tablet |
| lamotrigine 100 mg tablet, extended release | Generic | $0.6671 per tablet |
| lamotrigine 100 mg tablet, film coated, extended release | Generic | $0.6671 per tablet |
| lamotrigine 100 mg tablet, film coated, extended release | Brand: Lamictal XR | $30.37 per tablet |
| lamotrigine 100 mg tablet, orally disintegrating | Generic | $1.59 per tablet |
| lamotrigine 100 mg tablet, orally disintegrating | Brand: Lamictal ODT | $14.63 per tablet |
| lamotrigine 150 mg tablet | Generic | $0.0688 per tablet |
| lamotrigine 150 mg tablet | Brand: Lamictal | $11.46 per tablet |
| lamotrigine 200 mg tablet | Generic | $0.0801–$1.79 per tablet 21 packages, lowest to highest |
| lamotrigine 200 mg tablet | Brand: Lamictal | $12.04 per tablet |
| lamotrigine 200 mg tablet, extended release | Generic | $0.6485 per tablet |
| lamotrigine 200 mg tablet, film coated, extended release | Generic | $0.6485 per tablet |
| lamotrigine 200 mg tablet, film coated, extended release | Brand: Lamictal XR | $32.32 per tablet |
| lamotrigine 200 mg tablet, orally disintegrating | Generic | $1.79 per tablet |
| lamotrigine 200 mg tablet, orally disintegrating | Brand: Lamictal ODT | $17.49 per tablet |
| lamotrigine 25 mg tablet | Generic | $0.0270–$1.28 per tablet 23 packages, lowest to highest |
| lamotrigine 25 mg tablet | Brand: Lamictal | $10.28 per tablet |
| lamotrigine 25 mg tablet, chewable | Generic | $0.1503 per tablet |
| lamotrigine 25 mg tablet, extended release | Generic | $0.3615 per tablet |
| lamotrigine 25 mg tablet, film coated, extended release | Generic | $0.3615 per tablet |
| lamotrigine 25 mg tablet, film coated, extended release | Brand: Lamictal XR | $14.20 per tablet |
| lamotrigine 25 mg tablet, for suspension | Generic | $0.1503 per tablet |
| lamotrigine 25 mg tablet, for suspension | Brand: Lamictal | $11.17 per tablet |
| lamotrigine 25 mg tablet, orally disintegrating | Generic | $1.28 per tablet |
| lamotrigine 25 mg tablet, orally disintegrating | Brand: Lamictal ODT | $12.81 per tablet |
| lamotrigine 250 mg tablet, extended release | Generic | $1.21 per tablet |
| lamotrigine 250 mg tablet, film coated, extended release | Generic | $1.21 per tablet |
| lamotrigine 250 mg tablet, film coated, extended release | Brand: Lamictal XR | $44.21 per tablet |
| lamotrigine 300 mg tablet, extended release | Generic | $1.28 per tablet |
| lamotrigine 300 mg tablet, film coated, extended release | Generic | $1.28 per tablet |
| lamotrigine 300 mg tablet, film coated, extended release | Brand: Lamictal XR | $48.65 per tablet |
| lamotrigine 5 mg tablet, chewable | Generic | $0.1530 per tablet |
| lamotrigine 5 mg tablet, for suspension | Generic | $0.1530 per tablet |
| lamotrigine 50 mg tablet | Generic | $1.33 per tablet |
| lamotrigine 50 mg tablet, extended release | Generic | $0.5513 per tablet |
| lamotrigine 50 mg tablet, film coated, extended release | Generic | $0.5513 per tablet |
| lamotrigine 50 mg tablet, film coated, extended release | Brand: Lamictal XR | $28.35 per tablet |
| lamotrigine 50 mg tablet, orally disintegrating | Generic | $1.33 per tablet |
| lamotrigine 50 mg tablet, orally disintegrating | Brand: Lamictal ODT | $13.69 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- GlaxoSmithKline LLC17 products
- Remedyrepack Inc.15 products
- Zydus Lifesciences Limited14 products
- Zydus Pharmaceuticals USA Inc.14 products
- Alembic Pharmaceuticals Limited13 products
- Alembic Pharmaceuticals Inc.13 products
- Dr. Reddy's Laboratories Limited12 products
- Torrent Pharmaceuticals Limited11 products
- NorthStar Rx LLC10 products
- AvKARE10 products
- Bryant Ranch Prepack10 products
- Amneal Pharmaceuticals of New York LLC8 products
- Par Health USA, LLC8 products
- Sun Pharmaceutical Industries, Inc.8 products
- A-S Medication Solutions7 products
- Aurobindo Pharma Limited6 products
- Yiling Pharmaceutical, Inc.6 products
- Camber Pharmaceuticals, Inc.6 products
- Amneal Pharmaceuticals LLC6 products
- OWP Pharmaceuticals, Inc.6 products
- Proficient Rx LP5 products
- Advagen Pharma Limited4 products
- NCS HealthCare of KY, LLC dba Vangard Labs4 products
- Ajanta Pharma USA Inc.4 products
- Jubilant Cadista Pharmaceuticals Inc.4 products
- Golden State Medical Supply, Inc.4 products
- Dr.Reddys Laboratories Inc4 products
- ScieGen Pharmaceuticals, Inc.4 products
- Unichem Pharmaceuticals (USA), Inc.4 products
- Coupler LLC4 products
- Ascend Laboratories, LLC4 products
- Nordic Pharma, Inc.4 products
- Quallent Pharmaceuticals Health LLC4 products
- Actavis Pharma, Inc.4 products
- American Health Packaging4 products
- Direct_Rx3 products
- Cardinal Health 107, LLC3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Northwind Health Company, LLC3 products
- NuCare Pharmaceuticals, Inc.3 products
- Preferred Pharmaceuticals Inc.3 products
- Major Pharmaceuticals2 products
- Rising Pharma Holdings, Inc.2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Asclemed USA, Inc.1 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 |
|---|---|---|---|
| NDA020241 LAMICTAL | Glaxosmithkline LLC | December 27, 1994 | 49, latest October 10, 2025 2025: Labeling · 2025: Labeling · 2025: Labeling |
| NDA020764 LAMICTAL CD | Glaxosmithkline LLC | August 24, 1998 | 42, latest October 10, 2025 2025: Labeling · 2025: Labeling · 2025: Labeling |
| NDA022115 LAMICTAL XR | Glaxosmithkline LLC | May 29, 2009 | 26, latest October 10, 2025 2025: Labeling · 2025: Labeling · 2025: Labeling |
| NDA022251 LAMICTAL ODT | Glaxosmithkline LLC | May 8, 2009 | 25, latest October 10, 2025 2025: Labeling · 2025: Labeling · 2025: Labeling |
| NDA218879 SUBVENITE | Owp Pharms | September 16, 2025 | 2, latest July 17, 2026 2026: Labeling · 2026: Labeling |
Generic approvals (31)
- ANDA076701DR Reddys Labs Ltd · January 22, 2009
- ANDA078009Zydus Pharms USA Inc · January 22, 2009
- ANDA076708DR Reddys Labs Ltd · January 27, 2009
- ANDA077633Zydus Pharms USA · January 27, 2009
- ANDA078525Taro Pharm Inds · January 27, 2009
- ANDA078625Rubicon Research · January 27, 2009
- ANDA078947Torrent Pharms · January 27, 2009
- ANDA078956Aurobindo Pharma · January 27, 2009
- ANDA079132Jubilant Cadista · January 27, 2009
- ANDA079099Glenmark Pharms Ltd · February 19, 2009
- ANDA090401Aurobindo Pharma · November 4, 2009
- ANDA090607Alembic Pharms Ltd · January 13, 2011
- ANDA090170Unichem Labs Ltd · October 6, 2011
- ANDA201374Ph Health · December 26, 2012
- ANDA200694Alkem Labs Ltd · June 14, 2013
- ANDA202383DR Reddys Labs Ltd · June 19, 2013
- ANDA200828Impax Labs Inc · July 15, 2013
- ANDA200672Actavis Elizabeth · October 17, 2013
- ANDA203370Torrent · December 23, 2013
- ANDA201168Alembic · June 12, 2014
- ANDA204158Ph Health · October 27, 2015
- ANDA206382Sciegen Pharms · June 17, 2016
- ANDA207497Amneal Pharms · November 30, 2018
- ANDA207763Zydus Pharms · April 1, 2020
- ANDA213271Ajanta Pharma Ltd · January 19, 2021
- ANDA213949Pharmobedient · December 8, 2021
- ANDA214124J Molner · February 3, 2022
- ANDA211821Alembic · October 1, 2024
- ANDA219677Taro · October 7, 2025
- ANDA217100Torrent · January 8, 2026
- ANDA217278Alembic · February 25, 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.
-
July 20, 2022 · Class III · Terminated · D-1329-2022
Labeling: Label Error on Declared Strength
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4 — AVKARE Inc.
-
May 28, 2020 · Class III · Terminated · D-1289-2020
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478. — AVKARE Inc.
-
May 26, 2020 · Class III · Terminated · D-1281-2020
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 5974 — Jubilant Cadista Pharmaceuticals, Inc.
-
December 20, 2019 · Class I · Terminated · D-0833-2020
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1. — Taro Pharmaceuticals U.S.A., Inc.
-
September 11, 2018 · Class II · Terminated · D-1204-2018
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30 — Torrent Pharma Inc.
-
August 19, 2016 · Class III · Terminated · D-1519-2016
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), In — Unichem Pharmaceuticals Usa 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) | 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 199322, 201239 … (+10) |
|---|---|
| SPL set ID of the quoted label | d7e3572d-56fe-4727-2bb4-013ccca22678 |
| FDA labels (SPL) | 103 |
| FDA applications | NDA020241, NDA020764, NDA022115, NDA022251, NDA218879, 31 ANDA |
| Active ingredients (FDA) | LAMOTRIGINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lamictal, GlaxoSmithKline LLC, effective October 10, 2025; 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 →