FDA.reportPublic FDA data

Lamotrigine

Product NDC
68071-2054
11-digit product format
680712054
Labeler code
68071
Product ID
68071-2054_df63fed6-3ed3-70fa-e053-2a95a90a12ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090170
Marketing category
ANDA
Marketing start
2011-11-01
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
25 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
2023-12-31
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
68071-2054-42025-01-30C16284748780-12cef2736-6b30-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
68071-2054-92025-01-30C16284748780-12cef2736-6b30-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2054-4Lamotrigine42 in 1 BOTTLE, PLASTICTABLET422
68071-2054-9Lamotrigine90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2054LAMOTRIGINE TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230127_df63fe74-1225-0d83-e053-2995a90acca8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282401lamoTRIgine 25 MG Oral TabletPSNdf63fe74-1225-0d83-e053-2995a90acca82
282401lamotrigine 25 MG Oral TabletSCDdf63fe74-1225-0d83-e053-2995a90acca82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2054-46807120540442 in 1 BOTTLE, PLASTICHistorical
68071-2054-96807120540990 TABLET in 1 BOTTLE, PLASTIC (68071-2054-9) 90 tablet2022-05-190000-00-00NoNoCurrent