FDA.reportPublic FDA data

Lamotrigine

Product NDC
68084-318
11-digit product format
680840318
Labeler code
68084
Product ID
68084-318_275ca27b-4ae2-edea-e063-6394a90ab0c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077633
Marketing category
ANDA
Marketing start
2009-07-07
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
Rxcui198427, 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
68084-318-01Lamotrigine100 in 1 BOX, UNIT-DOSETABLET10016
68084-318-11Lamotrigine1 in 1 BLISTER PACKTABLET116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-318-01EA - Each68084-318ccfbe7a8-eae8-4992-bd95-057047adc61d12012-07-24
68084-318-11EA - Each68084-318e3c25130-aed5-4893-836f-fa396626d7f012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
POVIDONESINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-318LAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]16Current NDC, Legacy NDC, 2 package rows20241122_35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN35aa48a2-2ce6-4a6e-bf5a-1bc6111d123416
282401lamoTRIgine 25 MG Oral TabletPSN35aa48a2-2ce6-4a6e-bf5a-1bc6111d123416
198427lamotrigine 100 MG Oral TabletSCD35aa48a2-2ce6-4a6e-bf5a-1bc6111d123416
282401lamotrigine 25 MG Oral TabletSCD35aa48a2-2ce6-4a6e-bf5a-1bc6111d123416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-318-0168084031801100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-318-01) / 1 TABLET in 1 BLISTER PACK (68084-318-11) 100 blister pack2009-07-070000-00-00NoNoCurrent
68084-318-11680840318111 in 1 BLISTER PACKHistorical