FDA.reportPublic FDA data

Lamotrigine

Product NDC
68151-4249
11-digit product format
681514249
Labeler code
68151
Product ID
68151-4249_7e5d3d21-15dc-41c6-abf9-0834d4660965
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA076420
Marketing category
ANDA
Marketing start
2006-08-28
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
5 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
68151-4249-02020-01-31C16284748780-19d75b9cf-f473-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE) safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE). LAMOTRIGINE tablets (chewable, dispersible) for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4249-0Lamotrigine1 in 1 PACKAGETABLET, CHEWABLE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]2
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UILAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4249LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_a7455849-968d-4d85-8733-1e01701d7942.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311265lamoTRIgine 5 MG Tablet for Oral SuspensionPSNa7455849-968d-4d85-8733-1e01701d79423
311265lamotrigine 5 MG Tablet for Oral SuspensionSCDa7455849-968d-4d85-8733-1e01701d79423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4249-0681514249001 in 1 PACKAGEHistorical