FDA.reportPublic FDA data

LAMICTAL

Product NDC
0173-0779
11-digit product format
001730779
Labeler code
0173
Product ID
0173-0779_4492fd3c-e068-4599-8a10-0b26ea2a4f91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine
Dosage form
KIT
Labeler
GlaxoSmithKline LLC
Application
NDA022251
Marketing category
NDA
Marketing start
2009-06-05
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0779-00LAMICTALODT1 in 1 PACKAGE, COMBINATIONKIT144
0173-0779-00LAMICTALODT1 in 1 BLISTER PACKKIT144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0779-00EA - Each0173-0779353d597a-0738-42fc-97fd-101cdd6c3d0a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVLAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCLAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
MANNITOLINACTIVE INGREDIENT3OWL53L36ALAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
POVIDONESINACTIVE INGREDIENTFZ989GH94ELAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0779LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, FOR SUSPENSION LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]43Current NDC, Legacy NDC, 2 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
0173-0779-00001730779001 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0779-00) / 1 KIT in 1 BLISTER PACK1 blister pack2009-06-050000-00-00NoNoCurrent