Lamotrigine

Product NDC
50090-2992
11-digit product format
500902992
Labeler code
50090
Product ID
50090-2992_ebcc057f-edd4-4b6f-99af-ee6135c5bff2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090607
Marketing category
ANDA
Marketing start
2013-01-01
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2992-0Lamotrigine1 in 1 BLISTER PACKTABLET12
50090-2992-0Lamotrigine33 in 1 BOX, UNIT-DOSETABLET332

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2992LAMOTRIGINE TABLET [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20180308_60d33b54-bc36-42a8-8d32-342e307bd93c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282401lamoTRIgine 25 MG Oral TabletPSN60d33b54-bc36-42a8-8d32-342e307bd93c2
282401lamotrigine 25 MG Oral TabletSCD60d33b54-bc36-42a8-8d32-342e307bd93c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2992-0500902992001 in 1 BLISTER PACKHistorical