FDA.reportPublic FDA data

Lamotrigine

Product NDC
49884-487
11-digit product format
498840487
Labeler code
49884
Product ID
49884-487_983458ba-0e97-42af-952c-3662407dde00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA204158
Marketing category
ANDA
Marketing start
2015-12-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui103968, 198430, 252478, 252479, 851748, 851750, 851752

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
49884-487-11Lamotrigine30 in 1 DOSE PACKTABLET, ORALLY DISINTEGRATING3045
49884-487-41Lamotrigine14 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1445
49884-487-77Lamotrigine16 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1645

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-487-11EA - Each49884-487ef19cdac-a42a-48a4-87dd-fbf090d2a58812016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LamotrigineACTIVE INGREDIENTU3H27498KSLAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10
LamotrigineACTIVE MOIETYU3H27498KSLAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10
MANNITOLINACTIVE INGREDIENT3OWL53L36ALAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BLAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UILAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-487LAMOTRIGINE TABLET, ORALLY DISINTEGRATING LAMOTRIGINE KIT [ENDO USA, INC.]40Current NDC, Legacy NDC, 3 package rows20241212_003663e5-c0c7-4fc1-a64d-313f2a5b10d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
851752{14 (lamotrigine 100 MG Disintegrating Oral Tablet) / 42 (lamotrigine 50 MG Disintegrating Oral Tablet) } PackGPCK003663e5-c0c7-4fc1-a64d-313f2a5b10d245
851748{21 (lamotrigine 25 MG Disintegrating Oral Tablet) / 7 (lamotrigine 50 MG Disintegrating Oral Tablet) } PackGPCK003663e5-c0c7-4fc1-a64d-313f2a5b10d245
851750{7 (lamotrigine 100 MG Disintegrating Oral Tablet) / 14 (lamotrigine 25 MG Disintegrating Oral Tablet) / 14 (lamotrigine 50 MG Disintegrating Oral Tablet) } PackGPCK003663e5-c0c7-4fc1-a64d-313f2a5b10d245
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSN003663e5-c0c7-4fc1-a64d-313f2a5b10d245
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSN003663e5-c0c7-4fc1-a64d-313f2a5b10d245
851750lamoTRIgine 25 MG (14), 50 MG (14), 100 MG (7) Disintegrating Oral Tablet 35 Count PackPSN003663e5-c0c7-4fc1-a64d-313f2a5b10d245
851748lamoTRIgine 25 MG (21), 50 MG (7) Disintegrating Oral Tablet 28 Count PackPSN003663e5-c0c7-4fc1-a64d-313f2a5b10d245
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSN003663e5-c0c7-4fc1-a64d-313f2a5b10d245
851752lamoTRIgine 50 MG (42), 100 MG (14) Disintegrating Oral Tablet 56 Count PackPSN003663e5-c0c7-4fc1-a64d-313f2a5b10d245
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSN003663e5-c0c7-4fc1-a64d-313f2a5b10d245
103968lamotrigine 100 MG Disintegrating Oral TabletSCD003663e5-c0c7-4fc1-a64d-313f2a5b10d245
252479lamotrigine 200 MG Disintegrating Oral TabletSCD003663e5-c0c7-4fc1-a64d-313f2a5b10d245
198430lamotrigine 25 MG Disintegrating Oral TabletSCD003663e5-c0c7-4fc1-a64d-313f2a5b10d245
252478lamotrigine 50 MG Disintegrating Oral TabletSCD003663e5-c0c7-4fc1-a64d-313f2a5b10d245

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-487-114988404871130 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (49884-487-11) 2015-12-160000-00-00NoNoCurrent
49884-487-414988404874114 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-487-41) 2015-12-160000-00-00NoNoCurrent
49884-487-774988404877716 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-487-77) 2015-12-160000-00-00NoNoCurrent