FDA.reportPublic FDA data

Lamotrigine

Product NDC
0615-8267
11-digit product format
006158267
Labeler code
0615
Product ID
0615-8267_791b0966-9fe1-471d-9800-0c82e5751296
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA077633
Marketing category
ANDA
Marketing start
2009-01-27
Substance
LAMOTRIGINE
Active strength
200 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui198427, 198428, 198429, 282401

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8267-39Lamotrigine30 in 1 BLISTER PACKTABLET3028

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8267LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]28Current NDC, Legacy NDC, 1 package rows20240807_e243e803-e95f-47a6-a6da-5fed657f4462.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSNe243e803-e95f-47a6-a6da-5fed657f446228
198428lamoTRIgine 150 MG Oral TabletPSNe243e803-e95f-47a6-a6da-5fed657f446228
198429lamoTRIgine 200 MG Oral TabletPSNe243e803-e95f-47a6-a6da-5fed657f446228
282401lamoTRIgine 25 MG Oral TabletPSNe243e803-e95f-47a6-a6da-5fed657f446228
198427lamotrigine 100 MG Oral TabletSCDe243e803-e95f-47a6-a6da-5fed657f446228
198428lamotrigine 150 MG Oral TabletSCDe243e803-e95f-47a6-a6da-5fed657f446228
198429lamotrigine 200 MG Oral TabletSCDe243e803-e95f-47a6-a6da-5fed657f446228
282401lamotrigine 25 MG Oral TabletSCDe243e803-e95f-47a6-a6da-5fed657f446228

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8267-390061582673930 TABLET in 1 BLISTER PACK (0615-8267-39) 30 tablet2019-01-090000-00-00NoNoCurrent