FDA.reportPublic FDA data

Lamotrigine

Product NDC
68071-2873
11-digit product format
680712873
Labeler code
68071
Product ID
68071-2873_ed11262f-bfe2-4aee-e053-2995a90af901
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
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
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
68071-2873-32025-01-30C16284748780-12cef2736-9f7f-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
68071-2873-62025-01-30C16284748780-12cef2736-9f7f-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
68071-2873-3Lamotrigine30 in 1 BOTTLE, PLASTICTABLET302
68071-2873-6Lamotrigine60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2873LAMOTRIGINE TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230127_ed113525-f99c-70ab-e053-2995a90a062f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSNed113525-f99c-70ab-e053-2995a90a062f2
198427lamotrigine 100 MG Oral TabletSCDed113525-f99c-70ab-e053-2995a90a062f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2873-36807128730330 in 1 BOTTLE, PLASTICHistorical
68071-2873-66807128730660 TABLET in 1 BOTTLE, PLASTIC (68071-2873-6) 60 tablet2022-11-090000-00-00NoNoCurrent