FDA.reportPublic FDA data

Lamotrigine

Product NDC
68382-008
11-digit product format
683820008
Labeler code
68382
Product ID
68382-008_277200d5-a863-4411-8c1b-aac8d7fde6a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA077633
Marketing category
ANDA
Marketing start
2009-01-27
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
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
68382-008-01Lamotrigine100 in 1 BOTTLETABLET10029
68382-008-05Lamotrigine500 in 1 BOTTLETABLET50029
68382-008-10Lamotrigine1000 in 1 BOTTLETABLET100029
68382-008-16Lamotrigine90 in 1 BOTTLETABLET9029

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-008LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS USA INC.]28Current NDC, Legacy NDC, 4 package rows20250510_e849033b-a3bc-408e-88de-7cd1d2660949.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN4bbc140c-6092-416d-865d-49b89c5ecdd0101
198427lamotrigine 100 MG Oral TabletSCD4bbc140c-6092-416d-865d-49b89c5ecdd0101
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
198427lamoTRIgine 100 MG Oral TabletPSNe243e803-e95f-47a6-a6da-5fed657f446228
198428lamoTRIgine 150 MG Oral TabletPSNe243e803-e95f-47a6-a6da-5fed657f446228
198429lamoTRIgine 200 MG Oral TabletPSNe243e803-e95f-47a6-a6da-5fed657f446228
282401lamoTRIgine 25 MG Oral TabletPSNe243e803-e95f-47a6-a6da-5fed657f446228
198427lamotrigine 100 MG Oral TabletSCDe243e803-e95f-47a6-a6da-5fed657f446228
198428lamotrigine 150 MG Oral TabletSCDe243e803-e95f-47a6-a6da-5fed657f446228
198429lamotrigine 200 MG Oral TabletSCDe243e803-e95f-47a6-a6da-5fed657f446228
282401lamotrigine 25 MG Oral TabletSCDe243e803-e95f-47a6-a6da-5fed657f446228
198427lamoTRIgine 100 MG Oral TabletPSN35aa48a2-2ce6-4a6e-bf5a-1bc6111d123416
282401lamoTRIgine 25 MG Oral TabletPSN35aa48a2-2ce6-4a6e-bf5a-1bc6111d123416
198427lamotrigine 100 MG Oral TabletSCD35aa48a2-2ce6-4a6e-bf5a-1bc6111d123416
282401lamotrigine 25 MG Oral TabletSCD35aa48a2-2ce6-4a6e-bf5a-1bc6111d123416
198427lamoTRIgine 100 MG Oral TabletPSN15d801a0-f0a5-40c1-bc88-d5ba9a02c69614
198427lamotrigine 100 MG Oral TabletSCD15d801a0-f0a5-40c1-bc88-d5ba9a02c69614
198427lamoTRIgine 100 MG Oral TabletPSN35418581-1942-44e1-ab92-0653fa5f333610
198427lamoTRIgine 100 MG Oral TabletPSN12e0be85-0961-4fe0-b973-83251ecf0f6510
282401lamoTRIgine 25 MG Oral TabletPSN12e0be85-0961-4fe0-b973-83251ecf0f6510
198427lamotrigine 100 MG Oral TabletSCD35418581-1942-44e1-ab92-0653fa5f333610
198427lamotrigine 100 MG Oral TabletSCD12e0be85-0961-4fe0-b973-83251ecf0f6510
282401lamotrigine 25 MG Oral TabletSCD12e0be85-0961-4fe0-b973-83251ecf0f6510
198427lamoTRIgine 100 MG Oral TabletPSN31576d12-b9db-4668-a898-8864077b92667
198427lamotrigine 100 MG Oral TabletSCD31576d12-b9db-4668-a898-8864077b92667
198427lamoTRIgine 100 MG Oral TabletPSN634dbe6c-4874-4d54-aa25-be02d3341f166
198427lamotrigine 100 MG Oral TabletSCD634dbe6c-4874-4d54-aa25-be02d3341f166
198427lamoTRIgine 100 MG Oral TabletPSN03fd8413-df56-50ab-e063-6394a90a69503
198427lamotrigine 100 MG Oral TabletSCD03fd8413-df56-50ab-e063-6394a90a69503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-008-0168382000801100 TABLET in 1 BOTTLE (68382-008-01) 100 tablet2009-01-270000-00-00NoNoCurrent
68382-008-0568382000805500 TABLET in 1 BOTTLE (68382-008-05) 500 tablet2009-01-270000-00-00NoNoCurrent
68382-008-10683820008101000 TABLET in 1 BOTTLE (68382-008-10) 1000 tablet2009-01-270000-00-00NoNoCurrent
68382-008-166838200081690 TABLET in 1 BOTTLE (68382-008-16) 90 tablet2009-01-270000-00-00NoNoCurrent