FDA.reportPublic FDA data

Lamotrigine

Product NDC
33261-946
11-digit product format
332610946
Labeler code
33261
Product ID
33261-946_d62710fe-d3d0-4714-b3bb-e1f6dd916946
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA079132
Marketing category
ANDA
Marketing start
2009-01-27
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-946-602020-01-31C16284748780-19d75b9d0-a23a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Lamotrigine tablets safely and effectively. See full prescribing information for Lamotrigine. Lamotrigine Tablets, USP Rx Only Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-946-60Lamotrigine60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-946-60EA - Each33261-946fe7f4055-7d99-4f93-aeaa-090ccad23dcf12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-946LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140110_235c107d-24f7-4bf3-ac3a-3918ac1da88f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198429lamoTRIgine 200 MG Oral TabletPSN235c107d-24f7-4bf3-ac3a-3918ac1da88f1
282401lamoTRIgine 25 MG Oral TabletPSN235c107d-24f7-4bf3-ac3a-3918ac1da88f1
198429lamotrigine 200 MG Oral TabletSCD235c107d-24f7-4bf3-ac3a-3918ac1da88f1
282401lamotrigine 25 MG Oral TabletSCD235c107d-24f7-4bf3-ac3a-3918ac1da88f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-946-603326109466060 in 1 BOTTLE, PLASTICHistorical