FDA.reportPublic FDA data

Lamotrigine

Product NDC
0115-1526
11-digit product format
001151526
Labeler code
0115
Product ID
0115-1526_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
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
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
0115-1526-08Lamotrigine2 in 1 CARTONTABLET, ORALLY DISINTEGRATING213
0115-1526-68Lamotrigine15 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1526-08EA - Each0115-1526fa4fb8f8-3eca-496e-b2a7-b01257a7ad7612015-03-03
0115-1526-68EA - Each0115-152630ff1a0f-0181-4e81-bad9-75660e16974812018-05-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1526LAMOTRIGINE 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
0115-1526-08001151526082 BLISTER PACK in 1 CARTON (0115-1526-08) / 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1526-68) 2 blister pack2015-01-090000-00-00NoNoCurrent
0115-1526-680011515266815 in 1 BLISTER PACKHistorical