FDA.reportPublic FDA data

Lamotrigine

Product NDC
68382-109
11-digit product format
683820109
Labeler code
68382
Product ID
68382-109_277200d5-a863-4411-8c1b-aac8d7fde6a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078009
Marketing category
ANDA
Marketing start
2009-01-23
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, 199322, 249329, 282401, 311264, 311265

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
68382-109-01Lamotrigine100 in 1 BOTTLETABLET, CHEWABLE10029
68382-109-05Lamotrigine500 in 1 BOTTLETABLET, CHEWABLE50029
68382-109-16Lamotrigine90 in 1 BOTTLETABLET, CHEWABLE9029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-109-01EA - Each68382-109973fae19-e285-4202-9e12-ac150af5774912012-07-24
68382-109-05EA - Each68382-109da59c0af-9315-4e72-8724-0878723831fd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
BLACK CURRANTINACTIVE INGREDIENT9755T40D11LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
MANNITOLINACTIVE INGREDIENT3OWL53L36ALAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
POVIDONEINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-109LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS USA INC.]28Current NDC, Legacy NDC, 3 package rows20250510_e849033b-a3bc-408e-88de-7cd1d2660949.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSNe849033b-a3bc-408e-88de-7cd1d266094929
198428lamoTRIgine 150 MG Oral TabletPSNe849033b-a3bc-408e-88de-7cd1d266094929
198429lamoTRIgine 200 MG Oral TabletPSNe849033b-a3bc-408e-88de-7cd1d266094929
282401lamoTRIgine 25 MG Oral TabletPSNe849033b-a3bc-408e-88de-7cd1d266094929
311264lamoTRIgine 25 MG Tablet for Oral SuspensionPSNe849033b-a3bc-408e-88de-7cd1d266094929
249329lamoTRIgine 250 MG Oral TabletPSNe849033b-a3bc-408e-88de-7cd1d266094929
311265lamoTRIgine 5 MG Tablet for Oral SuspensionPSNe849033b-a3bc-408e-88de-7cd1d266094929
199322lamoTRIgine 50 MG Oral TabletPSNe849033b-a3bc-408e-88de-7cd1d266094929
198427lamotrigine 100 MG Oral TabletSCDe849033b-a3bc-408e-88de-7cd1d266094929
198428lamotrigine 150 MG Oral TabletSCDe849033b-a3bc-408e-88de-7cd1d266094929
198429lamotrigine 200 MG Oral TabletSCDe849033b-a3bc-408e-88de-7cd1d266094929
282401lamotrigine 25 MG Oral TabletSCDe849033b-a3bc-408e-88de-7cd1d266094929
311264lamotrigine 25 MG Tablet for Oral SuspensionSCDe849033b-a3bc-408e-88de-7cd1d266094929
249329lamotrigine 250 MG Oral TabletSCDe849033b-a3bc-408e-88de-7cd1d266094929
311265lamotrigine 5 MG Tablet for Oral SuspensionSCDe849033b-a3bc-408e-88de-7cd1d266094929
199322lamotrigine 50 MG Oral TabletSCDe849033b-a3bc-408e-88de-7cd1d266094929

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-109-0168382010901100 TABLET, CHEWABLE in 1 BOTTLE (68382-109-01) 2009-01-230000-00-00NoNoCurrent
68382-109-0568382010905500 TABLET, CHEWABLE in 1 BOTTLE (68382-109-05) 2009-01-230000-00-00NoNoCurrent
68382-109-166838201091690 TABLET, CHEWABLE in 1 BOTTLE (68382-109-16) 2009-01-230000-00-00NoNoCurrent