FDA.reportPublic FDA data

Lamotrigine

Product NDC
59746-245
11-digit product format
597460245
Labeler code
59746
Product ID
59746-245_1190d6b5-619e-46f0-aa54-7727eb4b183a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA079132
Marketing category
ANDA
Marketing start
2009-01-27
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, 198428, 198429, 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
59746-245-01Lamotrigine100 in 1 BOTTLETABLET10023
59746-245-05Lamotrigine500 in 1 BOTTLETABLET50023
59746-245-10Lamotrigine1000 in 1 BOTTLETABLET100023
59746-245-90Lamotrigine90 in 1 BOTTLETABLET9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-245-01EA - Each59746-245ec822e58-628b-4cf3-bf56-d907b12b6d3b12012-07-24
59746-245-05EA - Each59746-24575badd1a-f58e-4b20-a8f9-bab30893355212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE (LAMOTRIGINE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]15
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE (LAMOTRIGINE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE (LAMOTRIGINE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE (LAMOTRIGINE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE (LAMOTRIGINE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]15
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE (LAMOTRIGINE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]15
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
Starch, CornINACTIVE INGREDIENTO8232NY3SJLAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-245LAMOTRIGINE (LAMOTRIGINE) TABLET LAMOTRIGINE TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 4 package rows20210710_0b0f0209-edbd-46f3-9bed-762cbea0d737.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN0b0f0209-edbd-46f3-9bed-762cbea0d73723
198428lamoTRIgine 150 MG Oral TabletPSN0b0f0209-edbd-46f3-9bed-762cbea0d73723
198429lamoTRIgine 200 MG Oral TabletPSN0b0f0209-edbd-46f3-9bed-762cbea0d73723
282401lamoTRIgine 25 MG Oral TabletPSN0b0f0209-edbd-46f3-9bed-762cbea0d73723
198427lamotrigine 100 MG Oral TabletSCD0b0f0209-edbd-46f3-9bed-762cbea0d73723
198428lamotrigine 150 MG Oral TabletSCD0b0f0209-edbd-46f3-9bed-762cbea0d73723
198429lamotrigine 200 MG Oral TabletSCD0b0f0209-edbd-46f3-9bed-762cbea0d73723
282401lamotrigine 25 MG Oral TabletSCD0b0f0209-edbd-46f3-9bed-762cbea0d73723
198427lamoTRIgine 100 MG Oral TabletPSNfcdb94a8-33be-6375-98ef-6933999d157f17
198428lamoTRIgine 150 MG Oral TabletPSNfcdb94a8-33be-6375-98ef-6933999d157f17
198429lamoTRIgine 200 MG Oral TabletPSNfcdb94a8-33be-6375-98ef-6933999d157f17
282401lamoTRIgine 25 MG Oral TabletPSNfcdb94a8-33be-6375-98ef-6933999d157f17
198427lamotrigine 100 MG Oral TabletSCDfcdb94a8-33be-6375-98ef-6933999d157f17
198428lamotrigine 150 MG Oral TabletSCDfcdb94a8-33be-6375-98ef-6933999d157f17
198429lamotrigine 200 MG Oral TabletSCDfcdb94a8-33be-6375-98ef-6933999d157f17
282401lamotrigine 25 MG Oral TabletSCDfcdb94a8-33be-6375-98ef-6933999d157f17
198429lamoTRIgine 200 MG Oral TabletPSN235c107d-24f7-4bf3-ac3a-3918ac1da88f1
282401lamoTRIgine 25 MG Oral TabletPSN235c107d-24f7-4bf3-ac3a-3918ac1da88f1
198429lamotrigine 200 MG Oral TabletSCD235c107d-24f7-4bf3-ac3a-3918ac1da88f1
282401lamotrigine 25 MG Oral TabletSCD235c107d-24f7-4bf3-ac3a-3918ac1da88f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-245-0159746024501100 TABLET in 1 BOTTLE (59746-245-01) 100 tablet2009-01-270000-00-00NoNoCurrent
59746-245-0559746024505500 TABLET in 1 BOTTLE (59746-245-05) 500 tablet2009-01-270000-00-00NoNoCurrent
59746-245-10597460245101000 TABLET in 1 BOTTLE (59746-245-10) 1000 tablet2009-01-270000-00-00NoNoCurrent
59746-245-905974602459090 TABLET in 1 BOTTLE (59746-245-90) 90 tablet2009-01-27NoNoHistorical