FDA.reportPublic FDA data

Lamotrigine

Product NDC
71335-2384
11-digit product format
713352384
Labeler code
71335
Product ID
71335-2384_2cf33586-e48a-4b4e-b14b-33de2be63c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077633
Marketing category
ANDA
Marketing start
2009-01-27
Substance
LAMOTRIGINE
Active strength
25 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
LAMOTRIGINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui282401

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
71335-2384-1Lamotrigine30 in 1 BOTTLETABLET302
71335-2384-2Lamotrigine60 in 1 BOTTLETABLET602
71335-2384-3Lamotrigine90 in 1 BOTTLETABLET902
71335-2384-4Lamotrigine100 in 1 BOTTLETABLET1002
71335-2384-5Lamotrigine120 in 1 BOTTLETABLET1202
71335-2384-6Lamotrigine14 in 1 BOTTLETABLET142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2384LAMOTRIGINE TABLET [BRYANT RANCH PREPACK]1Current NDC, 6 package rows20240531_2cf33586-e48a-4b4e-b14b-33de2be63c1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282401lamoTRIgine 25 MG Oral TabletPSN2cf33586-e48a-4b4e-b14b-33de2be63c1d2
282401lamotrigine 25 MG Oral TabletSCD2cf33586-e48a-4b4e-b14b-33de2be63c1d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2384-17133523840130 TABLET in 1 BOTTLE (71335-2384-1) 30 tablet2024-09-06NoNoHistorical
71335-2384-27133523840260 TABLET in 1 BOTTLE (71335-2384-2) 60 tablet2025-06-16NoNoHistorical
71335-2384-37133523840390 TABLET in 1 BOTTLE (71335-2384-3) 90 tablet2025-06-16NoNoHistorical
71335-2384-471335238404100 TABLET in 1 BOTTLE (71335-2384-4) 100 tablet2024-03-28NoNoHistorical
71335-2384-571335238405120 TABLET in 1 BOTTLE (71335-2384-5) 120 tablet2024-04-15NoNoHistorical
71335-2384-67133523840614 TABLET in 1 BOTTLE (71335-2384-6) 14 tablet2025-06-16NoNoHistorical