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LAMICTAL

lamotrigine · Tablet, Orally Disintegrating

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 ODT
Generic name
lamotrigine
Dosage form
Tablet, Orally Disintegrating
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
4
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 200 mg/1 900156 View
Lamotrigine 25 mg/1 900156 View
Lamotrigine 50 mg/1 900156 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Orally Disintegrating
Route of administration
Oral
Presentations
8

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
022251
Application type
NDA · New Drug Application
Approval date
May 8, 2009
Sponsor
GLAXOSMITHKLINE LLC
Products on application
4
Submissions recorded
26
Products approved under application 022251.
Product Trade name Form Strength Ingredient Status TE Flags
022251-001 LAMICTAL ODT TABLET, ORALLY DISINTEGRATING LAMOTRIGINE Prescription AB RLD
022251-002 LAMICTAL ODT TABLET, ORALLY DISINTEGRATING LAMOTRIGINE Prescription AB RLD RS
022251-003 LAMICTAL ODT TABLET, ORALLY DISINTEGRATING LAMOTRIGINE Prescription AB RLD
022251-004 LAMICTAL ODT TABLET, ORALLY DISINTEGRATING LAMOTRIGINE Prescription AB RLD

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

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 022251.
Type No. Action Status Date Review
Supplement 33 Labeling Approved October 10, 2025 Standard
Supplement 32 Labeling Approved October 10, 2025 Standard
Supplement 31 Labeling Approved April 25, 2025 Standard
Supplement 30 Labeling Approved April 25, 2025 Standard
Supplement 28 Labeling Approved March 31, 2021 Standard
Supplement 22 Labeling Approved October 9, 2020 Standard
Supplement 26 Labeling Approved August 31, 2020 Standard
Supplement 25 Labeling Approved August 19, 2020 Standard
Supplement 24 Labeling Approved September 25, 2019 Standard
Supplement 23 Labeling Approved August 14, 2019 Standard
Supplement 20 Labeling Approved July 23, 2018 Standard
Supplement 21 Labeling Approved June 27, 2018 Standard
Supplement 17 Efficacy Approved May 18, 2015 Standard
Supplement 14 Labeling Approved March 24, 2015 Standard
Supplement 7 Labeling Approved March 24, 2015 Unknown
Supplement 9 Labeling Approved December 30, 2014 Unknown
Supplement 2 Labeling Approved December 30, 2014 Unknown
Supplement 16 Labeling Approved June 10, 2014 Standard
Supplement 1 Labeling Approved December 20, 2013 Unknown
Supplement 13 Labeling Approved August 1, 2012 Unknown
Supplement 12 Labeling Approved November 29, 2011 Unknown
Supplement 10 Labeling Approved August 4, 2011 Unknown
Supplement 11 REMS Approved May 31, 2011 N/A
Supplement 6 Labeling Approved October 24, 2010 Unknown
Supplement 5 REMS Approved October 24, 2010 N/A
Original application 1 Type 3 - New Dosage Form Approved May 8, 2009 Standard

Review documents

  • 0 · Supplement · October 15, 2025
  • 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 · 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 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

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
0173-0772-02 0173-0772 GlaxoSmithKline LLC 1 DOSE PACK in 1 CARTON (0173-0772-02) / 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK June 5, 2009
0173-0774-02 0173-0774 GlaxoSmithKline LLC 1 DOSE PACK in 1 CARTON (0173-0774-02) / 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK June 5, 2009
0173-0776-02 0173-0776 GlaxoSmithKline LLC 1 DOSE PACK in 1 CARTON (0173-0776-02) / 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK June 5, 2009
0173-0777-02 0173-0777 GlaxoSmithKline LLC 1 DOSE PACK in 1 CARTON (0173-0777-02) / 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK June 5, 2009
0173-0772 0173-0772 GlaxoSmithKline LLC — June 5, 2009
0173-0774 0173-0774 GlaxoSmithKline LLC — June 5, 2009
0173-0776 0173-0776 GlaxoSmithKline LLC — June 5, 2009
0173-0777 0173-0777 GlaxoSmithKline LLC — June 5, 2009

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.