FDA.reportPublic FDA data

Lamotrigine

Product NDC
0115-1528
11-digit product format
001151528
Labeler code
0115
Product ID
0115-1528_9611e358-6fe1-4f8d-99a2-250a7862a896
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA200828
Marketing category
ANDA
Marketing start
2015-01-09
Substance
LAMOTRIGINE
Active strength
100 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
LAMOTRIGINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui103968, 198430, 252478, 252479

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
0115-1528-08Lamotrigine3 in 1 CARTONTABLET, ORALLY DISINTEGRATING313
0115-1528-15Lamotrigine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1528LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Current NDC, Legacy NDC, 2 package rows20240101_380bddae-5b31-4965-96de-97711d859d11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSN380bddae-5b31-4965-96de-97711d859d1113
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSN380bddae-5b31-4965-96de-97711d859d1113
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSN380bddae-5b31-4965-96de-97711d859d1113
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSN380bddae-5b31-4965-96de-97711d859d1113
103968lamotrigine 100 MG Disintegrating Oral TabletSCD380bddae-5b31-4965-96de-97711d859d1113
252479lamotrigine 200 MG Disintegrating Oral TabletSCD380bddae-5b31-4965-96de-97711d859d1113
198430lamotrigine 25 MG Disintegrating Oral TabletSCD380bddae-5b31-4965-96de-97711d859d1113
252478lamotrigine 50 MG Disintegrating Oral TabletSCD380bddae-5b31-4965-96de-97711d859d1113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1528-08001151528083 BLISTER PACK in 1 CARTON (0115-1528-08) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1528-15) 3 blister pack2015-01-090000-00-00NoNoCurrent
0115-1528-150011515281510 in 1 BLISTER PACKHistorical