FDA.reportPublic FDA data

LAMICTAL

Product NDC
0173-0781
11-digit product format
001730781
Labeler code
0173
Product ID
0173-0781_0c7b21d8-3c32-4c65-95cd-cada0421d8e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA022115
Marketing category
NDA
Marketing start
2011-08-15
Substance
LAMOTRIGINE
Active strength
250 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
LAMICTAL
Brand name suffix
XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui850087, 850091, 900145, 900156, 900157, 900164, 900165, 900169, 900865, 900866, 900890, 900891, 900983, 900984, 1098608, 1098610, 1146690, 1146692

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0173-0781-002025-02-01C16284748780-12cef2736-ac26-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LAMICTAL XR safely and effectively. See full prescribing information for LAMICTAL XR. LAMICTAL XR (lamotrigine) extended-release tablets, for oral use Initial U.S. Approval: 1994
0173-0781-002025-02-01C16284748780-12cef2736-ac26-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LAMICTAL XR safely and effectively. See full prescribing information for LAMICTAL XR. LAMICTAL XR (lamotrigine) extended-release tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0781-00LAMICTALXR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0781-00EA - Each0173-078198ea5aa8-23fb-42cd-b917-5de26bbf6e5d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0781LAMICTAL XR (LAMOTRIGINE) TABLET, FILM COATED, EXTENDED RELEASE LAMICTAL XR (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]42Current NDC, Legacy NDC, 1 package rows20250507_3e2c9a35-6a39-41d7-ad84-3c0bb8894b09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900866{14 (24 HR lamotrigine 100 MG Extended Release Oral Tablet [Lamictal]) / 7 (24 HR lamotrigine 200 MG Extended Release Oral Tablet [Lamictal]) / 14 (24 HR lamotrigine 50 MG Extended Release Oral Tablet [Lamictal]) } Pack [Lamictal XR Green Patient Titration Kit (for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, and Not Taking Valproate)]BPCK3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900984{21 (24 HR lamotrigine 25 MG Extended Release Oral Tablet [Lamictal]) / 7 (24 HR lamotrigine 50 MG Extended Release Oral Tablet [Lamictal]) } Pack [Lamictal XR Blue Patient Titration Kit (for Patients Taking Valproate)]BPCK3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900891{7 (24 HR lamotrigine 100 MG Extended Release Oral Tablet [Lamictal]) / 14 (24 HR lamotrigine 25 MG Extended Release Oral Tablet [Lamictal]) / 14 (24 HR lamotrigine 50 MG Extended Release Oral Tablet [Lamictal]) } Pack [Lamictal XR Orange Patient Titration Kit (for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)]BPCK3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900865{14 (24 HR lamotrigine 100 MG Extended Release Oral Tablet) / 7 (24 HR lamotrigine 200 MG Extended Release Oral Tablet) / 14 (24 HR lamotrigine 50 MG Extended Release Oral Tablet) } PackGPCK3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900983{21 (24 HR lamotrigine 25 MG Extended Release Oral Tablet) / 7 (24 HR lamotrigine 50 MG Extended Release Oral Tablet) } PackGPCK3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900890{7 (24 HR lamotrigine 100 MG Extended Release Oral Tablet) / 14 (24 HR lamotrigine 25 MG Extended Release Oral Tablet) / 14 (24 HR lamotrigine 50 MG Extended Release Oral Tablet) } PackGPCK3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900145LaMICtal XR 100 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900157LaMICtal XR 200 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900165LaMICtal XR 25 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
1146692LaMICtal XR 250 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
1098610LaMICtal XR 300 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900169LaMICtal XR 50 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900984LaMICtal XR Patient Titration Kit Blue 25 MG (21), 50 MG (7) 28 CountPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900866LaMICtal XR Patient Titration Kit Green 50 MG (14), 100 MG (14), 200 MG (7) 35 CountPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900891LaMICtal XR Patient Titration Kit Orange 25 MG (14), 50 MG (14), 100 MG (7) 35 CountPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900983lamoTRIgine 25 MG (21), 50 MG (7) 24HR Extended Release Oral Tablet 28 Count PackPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900865lamoTRIgine 50 MG (14), 100 MG (14), 200 MG (7) 24 HR Extended Release Oral Tablet 35 Count PackPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSN3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
90014524 HR lamotrigine 100 MG Extended Release Oral Tablet [Lamictal]SBD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
90015724 HR lamotrigine 200 MG Extended Release Oral Tablet [Lamictal]SBD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
90016524 HR lamotrigine 25 MG Extended Release Oral Tablet [Lamictal]SBD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
114669224 HR lamotrigine 250 MG Extended Release Oral Tablet [Lamictal]SBD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
109861024 HR lamotrigine 300 MG Extended Release Oral Tablet [Lamictal]SBD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
90016924 HR lamotrigine 50 MG Extended Release Oral Tablet [Lamictal]SBD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCD3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
90086514 lamotrigine 100 MG 24 HR Extended Release Oral Tablet / 7 lamotrigine 200 MG 24 HR Extended Release Oral Tablet / 14 lamotrigine 50 MG 24 HR Extended Release Oral Tablet PackSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
90098321 lamotrigine 25 MG 24 HR Extended Release Oral Tablet / 7 lamotrigine 50 MG 24 HR Extended Release Oral Tablet PackSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
9008907 lamotrigine 100 MG 24 HR Extended Release Oral Tablet / 14 lamotrigine 25 MG 24 HR Extended Release Oral Tablet / 14 lamotrigine 50 MG 24 HR Extended Release Oral Tablet PackSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900145Lamictal 100 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900157Lamictal 200 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900165Lamictal 25 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
1146692Lamictal 250 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
1098610Lamictal 300 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900169Lamictal 50 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900145Lamictal XR 100 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900157Lamictal XR 200 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900165Lamictal XR 25 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
1146692Lamictal XR 250 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
1098610Lamictal XR 300 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900169Lamictal XR 50 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900984Lamictal XR Blue Patient Titration KitSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900984Lamictal XR Blue Patient Titration Kit (for Patients Taking Valproate)SY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900866Lamictal XR Green Patient Titration KitSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900866Lamictal XR Green Patient Titration Kit (for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, and Not Taking Valproate)SY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900891Lamictal XR Orange Patient Titration KitSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900891Lamictal XR Orange Patient Titration Kit (for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)SY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSY3e2c9a35-6a39-41d7-ad84-3c0bb8894b0943

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0173-0781-000017307810030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0781-00) 2011-08-150000-00-00NoNoCurrent