Lamotrigine

Product NDC
55154-2065
11-digit product format
551542065
Labeler code
55154
Product ID
55154-2065_1f211c99-9d3b-4fb7-8e82-a0e968e59fa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA077633
Marketing category
ANDA
Marketing start
2009-09-22
Substance
LAMOTRIGINE
Active strength
100 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
Lamotrigine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui198427

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
55154-2065-0Lamotrigine1 in 1 BAGTABLET119
55154-2065-0Lamotrigine10 in 1 BLISTER PACKTABLET1019

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [CARDINAL HEALTH]8
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [CARDINAL HEALTH]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [CARDINAL HEALTH]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [CARDINAL HEALTH]8
POVIDONESINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [CARDINAL HEALTH]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [CARDINAL HEALTH]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2065LAMOTRIGINE TABLET [CARDINAL HEALTH 107, LLC]18Current NDC, Legacy NDC, 2 package rows20241211_20e156df-a2b6-4710-b526-0419cd17dd33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN20e156df-a2b6-4710-b526-0419cd17dd3319
198427lamotrigine 100 MG Oral TabletSCD20e156df-a2b6-4710-b526-0419cd17dd3319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-2065-0551542065001 BLISTER PACK in 1 BAG (55154-2065-0) / 10 TABLET in 1 BLISTER PACK1 blister pack2009-09-220000-00-00NoNoCurrent