LAMOTRIGINE

Product NDC
61919-802
11-digit product format
619190802
Labeler code
61919
Product ID
61919-802_9c97707b-f86e-780f-e053-2995a90ad627
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090170
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
100 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
2021-12-31
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
61919-802-302023-01-30C16284748780-1f386c649-c710-0266-e053-dadaa90a7c1aLAMOTRIGINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-802-30LAMOTRIGINE30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-802LAMOTRIGINE TABLET [DIRECT RX]3Legacy NDC, 1 package rows20200130_b71ea970-4d53-44c2-aaed-19f2b5d22ce3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSNb71ea970-4d53-44c2-aaed-19f2b5d22ce33
198427lamotrigine 100 MG Oral TabletSCDb71ea970-4d53-44c2-aaed-19f2b5d22ce33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-802-306191908023030 TABLET in 1 BOTTLE (61919-802-30) 30 tablet2014-01-010000-00-00NoNoCurrent