FDA.reportPublic FDA data

Lamotrigine

Product NDC
65841-686
11-digit product format
658410686
Labeler code
65841
Product ID
65841-686_c4eb074b-9cd4-4bcd-868c-473d9364061c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
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, 199322, 249329, 282401, 311264, 311265

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-686-05Lamotrigine500 in 1 BOTTLETABLET50012
65841-686-14Lamotrigine60 in 1 BOTTLETABLET6012
65841-686-16Lamotrigine90 in 1 BOTTLETABLET9012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
BLACK CURRANTINACTIVE INGREDIENT9755T40D11LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-686LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 3 package rows20241204_0f2f7421-56d4-45d0-9d2d-dc1edaede039.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
198428lamoTRIgine 150 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
198429lamoTRIgine 200 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
282401lamoTRIgine 25 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
311264lamoTRIgine 25 MG Tablet for Oral SuspensionPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
249329lamoTRIgine 250 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
311265lamoTRIgine 5 MG Tablet for Oral SuspensionPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
199322lamoTRIgine 50 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
198427lamotrigine 100 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
198428lamotrigine 150 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
198429lamotrigine 200 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
282401lamotrigine 25 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
311264lamotrigine 25 MG Tablet for Oral SuspensionSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
249329lamotrigine 250 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
311265lamotrigine 5 MG Tablet for Oral SuspensionSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
199322lamotrigine 50 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-686-0565841068605500 TABLET in 1 BOTTLE (65841-686-05) 500 tablet2009-01-270000-00-00NoNoCurrent
65841-686-146584106861460 TABLET in 1 BOTTLE (65841-686-14) 60 tablet2009-01-270000-00-00NoNoCurrent
65841-686-166584106861690 TABLET in 1 BOTTLE (65841-686-16) 90 tablet2009-01-270000-00-00NoNoCurrent