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Active ingredient

Lamotrigine

289 finished FDA listings contain Lamotrigine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
LAMOTRIGINE
Dosage forms
Suspension, Tablet, Tablet, Chewable, Tablet, Extended Release, Tablet, Film Coated, Extended Release, Tablet, For Suspension, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
51
Strengths listed
10 mg/ml · 100 mg/1 · 150 mg/1 · 2 mg/1 · 200 mg/1 · 25 mg/1 · 250 mg/1 · 300 mg/1 · 5 mg/1 · 50 mg/1
Brand names in FDA listings
Lamictal, Lamictal Odt, Lamictal Xr, Lamotrigine, Lamotrigine Extended-Release, Subvenite

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 28439

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020241GLAXOSMITHKLINE LLC1994-12-274
NDA 020764GLAXOSMITHKLINE LLC1998-08-243
ANDA 078009ZYDUS PHARMS USA INC2009-01-224
ANDA 076701DR REDDYS LABS LTD2009-01-222
ANDA 078956AUROBINDO PHARMA2009-01-276
ANDA 078625RUBICON RESEARCH2009-01-274
ANDA 076708DR REDDYS LABS LTD2009-01-274
ANDA 079132JUBILANT CADISTA2009-01-279
ANDA 077633ZYDUS PHARMS USA2009-01-2741
ANDA 078947TORRENT PHARMS2009-01-2716
ANDA 078525TARO PHARM INDS2009-01-276
ANDA 079099GLENMARK PHARMS LTD2009-02-192
NDA 022251GLAXOSMITHKLINE LLC2009-05-084
NDA 022115GLAXOSMITHKLINE LLC2009-05-296
ANDA 090401AUROBINDO PHARMA2009-11-044
ANDA 090607ALEMBIC PHARMS LTD2011-01-138
ANDA 090170UNICHEM LABS LTD2011-10-0631
ANDA 201374PH HEALTH2012-12-264
ANDA 201791PH HEALTH2013-01-183
ANDA 200694ALKEM LABS LTD2013-06-144
ANDA 202383DR REDDYS LABS LTD2013-06-1913
ANDA 200828IMPAX LABS INC2013-07-158
ANDA 200672ACTAVIS ELIZABETH2013-10-175
ANDA 203370TORRENT2013-12-235
ANDA 201168ALEMBIC2014-06-124
ANDA 204158PH HEALTH2015-10-274
ANDA 206382SCIEGEN PHARMS2016-06-178
ANDA 207497AMNEAL PHARMS2018-11-3012
ANDA 207763ZYDUS PHARMS2020-04-0114
ANDA 213271AJANTA PHARMA LTD2021-01-194
ANDA 213949YILING2021-12-0816
ANDA 214124J MOLNER2022-02-034
ANDA 211821ALEMBIC2024-10-016
NDA 218879OWP PHARMS2025-09-161
ANDA 219677TARO2025-10-078
ANDA 217100TORRENT2026-01-084
ANDA 217278ALEMBIC2026-02-258

Official labeling on DailyMed

Showing the 12 most recent of 107 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.