FDA.reportPublic FDA data

LAMICTAL

Product NDC
0173-0643
11-digit product format
001730643
Labeler code
0173
Product ID
0173-0643_4492fd3c-e068-4599-8a10-0b26ea2a4f91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA020241
Marketing category
NDA
Marketing start
1995-01-17
Substance
LAMOTRIGINE
Active strength
150 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LAMICTAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, 206201, 252478, 252479, 282401, 311264, 311265, 349010, 542426, 751139, 751563

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0173-0643-602025-02-01C16284748780-12cef2736-673a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) tablets, for oral use LAMICTAL (lamotrigine) tablets for oral suspension LAMICTAL ODT (lamotrigine) orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
0173-0643-602025-02-01C16284748780-12cef2736-673a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) tablets, for oral use LAMICTAL (lamotrigine) tablets for oral suspension LAMICTAL ODT (lamotrigine) orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
0173-0643-602025-01-30C16284748780-12cef2736-673a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) tablets, for oral use LAMICTAL (lamotrigine) tablets for oral suspension LAMICTAL ODT (lamotrigine) orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
0173-0643-602025-01-30C16284748780-12cef2736-673a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) tablets, for oral use LAMICTAL (lamotrigine) tablets for oral suspension LAMICTAL ODT (lamotrigine) orally disintegrating tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0643-60LAMICTAL60 in 1 BOTTLETABLET6044

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0643LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, FOR SUSPENSION LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]43Current NDC, Legacy NDC, 1 package rows20250507_d7e3572d-56fe-4727-2bb4-013ccca22678.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
851753{14 (lamotrigine 100 MG Disintegrating Oral Tablet [Lamictal]) / 42 (lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]) } Pack [Lamictal ODT Green Titration Kit (for Patients Taking Enzyme-Inducing Drugs and Not Taking Valproate)]BPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
795778{14 (lamotrigine 100 MG Oral Tablet [Lamictal]) / 84 (lamotrigine 25 MG Oral Tablet [Lamictal]) } Pack [Lamictal Green (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)]BPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
851749{21 (lamotrigine 25 MG Disintegrating Oral Tablet [Lamictal]) / 7 (lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]) } Pack [Lamictal ODT Blue Patient Titration Kit (for Patients Taking Valproate)]BPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
795772{35 (lamotrigine 25 MG Oral Tablet [Lamictal]) } Pack [Lamictal Blue (For Patients Taking Valproate)]BPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
851751{7 (lamotrigine 100 MG Disintegrating Oral Tablet [Lamictal]) / 14 (lamotrigine 25 MG Disintegrating Oral Tablet [Lamictal]) / 14 (lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]) } Pack [Lamictal ODT Orange Patient Titration Kit (For Patients Not Taking Enzyme-Inducing Drugs or Valproate)]BPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
795774{7 (lamotrigine 100 MG Oral Tablet [Lamictal]) / 42 (lamotrigine 25 MG Oral Tablet [Lamictal]) } Pack [Lamictal Orange (For Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)]BPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
851752{14 (lamotrigine 100 MG Disintegrating Oral Tablet) / 42 (lamotrigine 50 MG Disintegrating Oral Tablet) } PackGPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
753451{14 (lamotrigine 100 MG Oral Tablet) / 84 (lamotrigine 25 MG Oral Tablet) } PackGPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
851748{21 (lamotrigine 25 MG Disintegrating Oral Tablet) / 7 (lamotrigine 50 MG Disintegrating Oral Tablet) } PackGPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
751139{35 (lamotrigine 25 MG Oral Tablet) } PackGPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
851750{7 (lamotrigine 100 MG Disintegrating Oral Tablet) / 14 (lamotrigine 25 MG Disintegrating Oral Tablet) / 14 (lamotrigine 50 MG Disintegrating Oral Tablet) } PackGPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
751563{7 (lamotrigine 100 MG Oral Tablet) / 42 (lamotrigine 25 MG Oral Tablet) } PackGPCKd7e3572d-56fe-4727-2bb4-013ccca2267844
105018LaMICtal 100 MG Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
206201LaMICtal 150 MG Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
542426LaMICtal 2 MG Tablet for Oral SuspensionPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
108782LaMICtal 200 MG Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
105019LaMICtal 25 MG Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
201240LaMICtal 25 MG Tablet for Oral SuspensionPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
201239LaMICtal 5 MG Tablet for Oral SuspensionPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
849049LaMICtal ODT 100 MG Disintegrating Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
849050LaMICtal ODT 200 MG Disintegrating Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
849051LaMICtal ODT 25 MG Disintegrating Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
849052LaMICtal ODT 50 MG Disintegrating Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
851749LaMICtal ODT Patient Titration Kit Blue 25 MG (21), 50 MG (7) 28 CountPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
851753LaMICtal ODT Patient Titration Kit Green 50 MG (42), 100 MG (14) 56 CountPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
851751LaMICtal ODT Patient Titration Kit Orange 25 MG (14), 50 MG (14), 100 MG (7) 35 CountPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
795772LaMICtal Starter Kit Blue 25 MG 35 CountPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
795778LaMICtal Starter Kit Green 25 MG (84), 100 MG (14) 98 CountPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
795774LaMICtal Starter Kit Orange 25 MG (42), 100 MG (7) 49 CountPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
198427lamoTRIgine 100 MG Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
198428lamoTRIgine 150 MG Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
349010lamoTRIgine 2 MG Tablet for Oral SuspensionPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
198429lamoTRIgine 200 MG Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
851750lamoTRIgine 25 MG (14), 50 MG (14), 100 MG (7) Disintegrating Oral Tablet 35 Count PackPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
851748lamoTRIgine 25 MG (21), 50 MG (7) Disintegrating Oral Tablet 28 Count PackPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
751563lamoTRIgine 25 MG (42), 100 MG (7) Oral Tablet 49 Count PackPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
753451lamoTRIgine 25 MG (84), 100 MG (14) Oral Tablet 98 Count PackPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
282401lamoTRIgine 25 MG Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
751139lamoTRIgine 25 MG Oral Tablet 35 Count PackPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
311264lamoTRIgine 25 MG Tablet for Oral SuspensionPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
311265lamoTRIgine 5 MG Tablet for Oral SuspensionPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
851752lamoTRIgine 50 MG (42), 100 MG (14) Disintegrating Oral Tablet 56 Count PackPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSNd7e3572d-56fe-4727-2bb4-013ccca2267844
849049lamotrigine 100 MG Disintegrating Oral Tablet [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
105018lamotrigine 100 MG Oral Tablet [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
206201lamotrigine 150 MG Oral Tablet [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
542426lamotrigine 2 MG Tablet for Oral Suspension [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
849050lamotrigine 200 MG Disintegrating Oral Tablet [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
108782lamotrigine 200 MG Oral Tablet [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
849051lamotrigine 25 MG Disintegrating Oral Tablet [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
105019lamotrigine 25 MG Oral Tablet [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
201240lamotrigine 25 MG Tablet for Oral Suspension [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
201239lamotrigine 5 MG Tablet for Oral Suspension [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
849052lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]SBDd7e3572d-56fe-4727-2bb4-013ccca2267844
103968lamotrigine 100 MG Disintegrating Oral TabletSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
198427lamotrigine 100 MG Oral TabletSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
198428lamotrigine 150 MG Oral TabletSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
349010lamotrigine 2 MG Tablet for Oral SuspensionSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
252479lamotrigine 200 MG Disintegrating Oral TabletSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
198429lamotrigine 200 MG Oral TabletSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
198430lamotrigine 25 MG Disintegrating Oral TabletSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
282401lamotrigine 25 MG Oral TabletSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
311264lamotrigine 25 MG Tablet for Oral SuspensionSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
311265lamotrigine 5 MG Tablet for Oral SuspensionSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
252478lamotrigine 50 MG Disintegrating Oral TabletSCDd7e3572d-56fe-4727-2bb4-013ccca2267844
105018Lamictal 100 MG Oral TabletSYd7e3572d-56fe-4727-2bb4-013ccca2267844
206201Lamictal 150 MG Oral TabletSYd7e3572d-56fe-4727-2bb4-013ccca2267844
542426Lamictal 2 MG Tablet for Oral SuspensionSYd7e3572d-56fe-4727-2bb4-013ccca2267844
108782Lamictal 200 MG Oral TabletSYd7e3572d-56fe-4727-2bb4-013ccca2267844
105019Lamictal 25 MG Oral TabletSYd7e3572d-56fe-4727-2bb4-013ccca2267844
795772Lamictal Blue (For Patients Taking Valproate)SYd7e3572d-56fe-4727-2bb4-013ccca2267844
542426Lamictal CD 2 MG Tablet for Oral SuspensionSYd7e3572d-56fe-4727-2bb4-013ccca2267844
201240Lamictal CD 25 MG Tablet for Oral SuspensionSYd7e3572d-56fe-4727-2bb4-013ccca2267844
201239Lamictal CD 5 MG Tablet for Oral SuspensionSYd7e3572d-56fe-4727-2bb4-013ccca2267844
795778Lamictal Green Kit (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)SYd7e3572d-56fe-4727-2bb4-013ccca2267844
849049Lamictal ODT 100 MG Disintegrating Oral TabletSYd7e3572d-56fe-4727-2bb4-013ccca2267844
849050Lamictal ODT 200 MG Disintegrating Oral TabletSYd7e3572d-56fe-4727-2bb4-013ccca2267844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0643-600017306436060 TABLET in 1 BOTTLE (0173-0643-60) 60 tablet1995-01-170000-00-00NoNoCurrent