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LAMICTAL

lamotrigine · Tablet

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
LAMICTAL
Generic name
lamotrigine
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
GlaxoSmithKline LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
5
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Lamotrigine 100 mg/1 900156 View
Lamotrigine 150 mg/1 900156 View
Lamotrigine 200 mg/1 900156 View
Lamotrigine 25 mg/1 900156 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
9

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-epileptic Agent [EPC] EPC All 62 members
Decreased Central Nervous System Disorganized Electrical Activity [PE] PE All 114 members
Dihydrofolate Reductase Inhibitors [MoA] MoA All 25 members
Mood Stabilizer [EPC] EPC All 41 members
Organic Cation Transporter 2 Inhibitors [MoA] MoA All 32 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020241
Application type
NDA · New Drug Application
Approval date
December 27, 1994
Sponsor
GLAXOSMITHKLINE LLC
Products on application
6
Submissions recorded
50
Products approved under application 020241.
Product Trade name Form Strength Ingredient Status TE Flags
020241-001 LAMICTAL TABLET LAMOTRIGINE Prescription AB RLD
020241-002 LAMICTAL TABLET LAMOTRIGINE Prescription AB RLD
020241-003 LAMICTAL TABLET LAMOTRIGINE Prescription AB RLD
020241-004 LAMICTAL TABLET LAMOTRIGINE Discontinued — RLD
020241-005 LAMICTAL TABLET LAMOTRIGINE Prescription AB RLD
020241-006 LAMICTAL TABLET LAMOTRIGINE Discontinued — RLD

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020241.
Type No. Action Status Date Review
Supplement 69 Labeling Approved October 10, 2025 Standard
Supplement 68 Labeling Approved October 10, 2025 Standard
Supplement 67 Labeling Approved April 25, 2025 Standard
Supplement 66 Labeling Approved April 25, 2025 Standard
Supplement 64 Labeling Approved March 31, 2021 Standard
Supplement 58 Labeling Approved October 9, 2020 Standard
Supplement 62 Labeling Approved August 31, 2020 Standard
Supplement 61 Labeling Approved August 19, 2020 Standard
Supplement 60 Labeling Approved September 25, 2019 Standard
Supplement 59 Labeling Approved August 14, 2019 Standard
Supplement 56 Labeling Approved July 23, 2018 Standard
Supplement 57 Labeling Approved June 27, 2018 Standard
Supplement 53 Efficacy Approved May 18, 2015 Standard
Supplement 51 Labeling Approved March 24, 2015 Standard
Supplement 45 Labeling Approved March 24, 2015 Standard
Supplement 40 Labeling Approved December 30, 2014 Unknown
Supplement 35 Labeling Approved December 30, 2014 Standard
Supplement 52 Labeling Approved June 10, 2014 Standard
Supplement 39 Labeling Approved December 20, 2013 Unknown
Supplement 50 Labeling Approved August 1, 2012 Unknown
Supplement 49 Labeling Approved November 29, 2011 Unknown
Supplement 47 Labeling Approved August 4, 2011 Unknown
Supplement 48 REMS Approved May 31, 2011 N/A
Supplement 44 Labeling Approved October 24, 2010 Unknown
Supplement 43 REMS Approved October 24, 2010 N/A
Supplement 36 Labeling Approved May 8, 2009 Standard
Supplement 38 Labeling Approved April 23, 2009 Standard
Supplement 37 Labeling Approved April 23, 2009 901 Required
Supplement 26 Labeling Approved September 25, 2006 Standard
Supplement 25 Labeling Approved September 25, 2006 Standard
Supplement 21 Labeling Approved September 25, 2006 Standard
Supplement 10 Labeling Approved September 25, 2006 Standard
Supplement 27 Efficacy Approved September 22, 2006 Standard
Supplement 29 Labeling Approved March 17, 2006 Standard
Supplement 16 Efficacy Approved January 14, 2004 Standard
Supplement 17 Efficacy Approved June 20, 2003 Standard
Supplement 18 Labeling Approved April 4, 2003 Standard
Supplement 8 Efficacy Approved January 17, 2003 Standard
Supplement 11 Efficacy Approved May 25, 2001 Standard
Supplement 15 Labeling Approved February 23, 2001 Standard
Supplement 14 Labeling Approved September 8, 2000 Standard
Supplement 12 Manufacturing (CMC) Approved June 12, 2000 Priority
Supplement 9 Manufacturing (CMC) Approved June 8, 1999 Priority
Supplement 7 Manufacturing (CMC) Approved May 10, 1999 Priority
Supplement 3 Efficacy Approved December 14, 1998 Standard
Supplement 2 Efficacy Approved August 24, 1998 Standard
Supplement 6 Labeling Approved March 16, 1998 Standard
Supplement 5 Manufacturing (CMC) Approved March 16, 1998 Priority
Supplement 4 Labeling Approved March 11, 1997 Standard
Original application 1 Type 1 - New Molecular Entity Approved December 27, 1994 Priority

Review documents

  • 0 · Supplement · October 15, 2025
  • 0 · Supplement · October 14, 2025
  • 0 · Supplement · October 14, 2025
  • 0 · Supplement · October 14, 2025
  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · April 29, 2025
  • 0 · Supplement · April 29, 2025
  • 0 · Supplement · April 1, 2021
  • 0 · Supplement · April 1, 2021
  • 0 · Supplement · October 14, 2020
  • 0 · Supplement · October 14, 2020
  • 0 · Supplement · September 11, 2020
  • 0 · Supplement · September 11, 2020
  • 0 · Supplement · September 4, 2020
  • 0 · Supplement · September 1, 2020
  • 0 · Supplement · August 19, 2020
  • 0 · Supplement · September 26, 2019
  • 0 · Supplement · September 26, 2019
  • 0 · Supplement · August 15, 2019
  • 0 · Supplement · August 15, 2019
  • 0 · Supplement · July 26, 2018
  • 0 · Supplement · July 24, 2018
  • 0 · Supplement · July 6, 2018
  • 0 · Supplement · July 5, 2018
  • 0 · Supplement · May 21, 2015
  • 0 · Supplement · May 20, 2015
  • 0 · Supplement · March 25, 2015
  • 0 · Supplement · March 25, 2015
  • 0 · Supplement · March 25, 2015

Adverse event reports

Source: openFDA FAERS
131,122
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LAMOTRIGINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0173-0633-02 0173-0633 GlaxoSmithKline LLC 100 TABLET in 1 BOTTLE (0173-0633-02) August 15, 1996
0173-0633-10 0173-0633 GlaxoSmithKline LLC 35 TABLET in 1 DOSE PACK (0173-0633-10) August 15, 1996
0173-0642-55 0173-0642 GlaxoSmithKline LLC 100 TABLET in 1 BOTTLE (0173-0642-55) January 17, 1995
0173-0643-60 0173-0643 GlaxoSmithKline LLC 60 TABLET in 1 BOTTLE (0173-0643-60) January 17, 1995
0173-0644-60 0173-0644 GlaxoSmithKline LLC 60 TABLET in 1 BOTTLE (0173-0644-60) January 18, 1995
0173-0633 0173-0633 GlaxoSmithKline LLC — August 15, 1996
0173-0642 0173-0642 GlaxoSmithKline LLC — January 17, 1995
0173-0643 0173-0643 GlaxoSmithKline LLC — January 17, 1995
0173-0644 0173-0644 GlaxoSmithKline LLC — January 18, 1995

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.