Lamotrigine

Product NDC
71335-2071
11-digit product format
713352071
Labeler code
71335
Product ID
71335-2071_578c32bb-d9d4-48a7-9b64-28991e1a5750
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078525
Marketing category
ANDA
Marketing start
2009-01-27
Substance
LAMOTRIGINE
Active strength
150 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui198428

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
71335-2071-1Lamotrigine60 in 1 BOTTLETABLET60102
71335-2071-2Lamotrigine30 in 1 BOTTLETABLET30102
71335-2071-3Lamotrigine90 in 1 BOTTLETABLET90102
71335-2071-4Lamotrigine120 in 1 BOTTLETABLET120102
71335-2071-5Lamotrigine180 in 1 BOTTLETABLET180102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2071LAMOTRIGINE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240420_68a4dac2-5015-40c5-88ca-204098c3b288.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198428lamoTRIgine 150 MG Oral TabletPSN68a4dac2-5015-40c5-88ca-204098c3b288103
198428lamotrigine 150 MG Oral TabletSCD68a4dac2-5015-40c5-88ca-204098c3b288103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2071-17133520710160 TABLET in 1 BOTTLE (71335-2071-1) 60 tablet2024-04-030000-00-00NoNoCurrent
71335-2071-27133520710230 TABLET in 1 BOTTLE (71335-2071-2) 30 tablet2022-03-250000-00-00NoNoCurrent
71335-2071-37133520710390 TABLET in 1 BOTTLE (71335-2071-3) 90 tablet2024-04-030000-00-00NoNoCurrent
71335-2071-471335207104120 TABLET in 1 BOTTLE (71335-2071-4) 120 tablet2024-04-030000-00-00NoNoCurrent
71335-2071-571335207105180 TABLET in 1 BOTTLE (71335-2071-5) 180 tablet2024-04-030000-00-00NoNoCurrent