FDA.reportPublic FDA data

Lamotrigine

Product NDC
71335-1469
11-digit product format
713351469
Labeler code
71335
Product ID
71335-1469_917573a6-61bf-4b9c-8eba-cc4c79935072
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200672
Marketing category
ANDA
Marketing start
2016-04-01
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
Rxcui900164

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1469-12024-05-21C16284748780-11030e365-1aea-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LAMOTRIGINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE EXTENDED-RELEASE TABLETS. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
71335-1469-12024-01-30C16284748780-11030e365-1aea-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LAMOTRIGINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE EXTENDED-RELEASE TABLETS. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1469-1Lamotrigine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1469LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 1 package rows20240522_36f383af-8b71-4875-85ef-3a7a8b1d8805.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSN36f383af-8b71-4875-85ef-3a7a8b1d88053
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCD36f383af-8b71-4875-85ef-3a7a8b1d88053
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSY36f383af-8b71-4875-85ef-3a7a8b1d88053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1469-17133514690130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1469-1) 2020-01-100000-00-00NoNoCurrent