FDA.reportPublic FDA data

Lamotrigine

Product NDC
50090-2129
11-digit product format
500902129
Labeler code
50090
Product ID
50090-2129_ef0d9729-3dc1-420d-9486-65e6084994e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090170
Marketing category
ANDA
Marketing start
2011-11-01
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
25 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
2022-12-31
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
50090-2129-02023-02-07C16284748780-1f386c649-b574-0266-e053-dadaa90a7c1aThese 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
50090-2129-12023-02-07C16284748780-1f386c649-b574-0266-e053-dadaa90a7c1aThese 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
50090-2129-22023-02-07C16284748780-1f386c649-b574-0266-e053-dadaa90a7c1aThese 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
50090-2129-02023-01-30C16284748780-1f386c649-b574-0266-e053-dadaa90a7c1aThese 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
50090-2129-12023-01-30C16284748780-1f386c649-b574-0266-e053-dadaa90a7c1aThese 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
50090-2129-22023-01-30C16284748780-1f386c649-b574-0266-e053-dadaa90a7c1aThese 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
50090-2129-0Lamotrigine60 in 1 BOTTLETABLET6028
50090-2129-1Lamotrigine180 in 1 BOTTLETABLET18028
50090-2129-2Lamotrigine30 in 1 BOTTLETABLET3028

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2129LAMOTRIGINE TABLET [A-S MEDICATION SOLUTIONS]25Legacy NDC, 3 package rows20240824_6139a858-700c-4eb9-9f84-99d280bde326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN6139a858-700c-4eb9-9f84-99d280bde32628
198428lamoTRIgine 150 MG Oral TabletPSN6139a858-700c-4eb9-9f84-99d280bde32628
282401lamoTRIgine 25 MG Oral TabletPSN6139a858-700c-4eb9-9f84-99d280bde32628
198427lamotrigine 100 MG Oral TabletSCD6139a858-700c-4eb9-9f84-99d280bde32628
198428lamotrigine 150 MG Oral TabletSCD6139a858-700c-4eb9-9f84-99d280bde32628
282401lamotrigine 25 MG Oral TabletSCD6139a858-700c-4eb9-9f84-99d280bde32628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2129-05009021290060 TABLET in 1 BOTTLE (50090-2129-0) 60 tablet2015-10-150000-00-00NoNoCurrent
50090-2129-150090212901180 TABLET in 1 BOTTLE (50090-2129-1) 180 tablet2019-09-250000-00-00NoNoCurrent
50090-2129-25009021290230 TABLET in 1 BOTTLE (50090-2129-2) 30 tablet2020-01-220000-00-00NoNoCurrent