FDA.reportPublic FDA data

Lamotrigine

Product NDC
0093-7248
11-digit product format
000937248
Labeler code
0093
Product ID
0093-7248_bfe86f59-2ea1-4ba4-a652-e005bcff313c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076388
Marketing category
ANDA
Marketing start
2008-07-22
Marketing end
2019-12-31
Substance
LAMOTRIGINE
Active strength
200 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
0000-00-00
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN6c925a5d-e154-475c-8478-ab7a271d68b910
198428lamoTRIgine 150 MG Oral TabletPSN6c925a5d-e154-475c-8478-ab7a271d68b910
198429lamoTRIgine 200 MG Oral TabletPSN6c925a5d-e154-475c-8478-ab7a271d68b910
282401lamoTRIgine 25 MG Oral TabletPSN6c925a5d-e154-475c-8478-ab7a271d68b910
198427lamotrigine 100 MG Oral TabletSCD6c925a5d-e154-475c-8478-ab7a271d68b910
198428lamotrigine 150 MG Oral TabletSCD6c925a5d-e154-475c-8478-ab7a271d68b910
198429lamotrigine 200 MG Oral TabletSCD6c925a5d-e154-475c-8478-ab7a271d68b910
282401lamotrigine 25 MG Oral TabletSCD6c925a5d-e154-475c-8478-ab7a271d68b910
198427lamoTRIgine 100 MG Oral TabletPSN11800356-759d-4a8d-8811-e7942a3db6f51
198429lamoTRIgine 200 MG Oral TabletPSN11800356-759d-4a8d-8811-e7942a3db6f51
198427lamotrigine 100 MG Oral TabletSCD11800356-759d-4a8d-8811-e7942a3db6f51
198429lamotrigine 200 MG Oral TabletSCD11800356-759d-4a8d-8811-e7942a3db6f51