FDA.reportPublic FDA data

Lamotrigine

Product NDC
65862-230
11-digit product format
658620230
Labeler code
65862
Product ID
65862-230_fa1b319e-3ee3-41e0-8986-7b42885935f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078956
Marketing category
ANDA
Marketing start
2009-01-27
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
2026-12-31
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

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
65862-230-01Lamotrigine100 in 1 BOTTLETABLET10030
65862-230-10Lamotrigine10 in 1 BLISTER PACKTABLET1030
65862-230-60Lamotrigine60 in 1 BOTTLETABLET6030
65862-230-78Lamotrigine10 in 1 CARTONTABLET1030
65862-230-99Lamotrigine1000 in 1 BOTTLETABLET100030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-230-01EA - Each65862-230d83723e4-84bb-492a-81e0-bcd9b552a23312012-07-24
65862-230-60EA - Each65862-230d4414ab8-0629-4cf4-9bf9-4a33c4a7a32f12012-07-24
65862-230-99EA - Each65862-230fc39e60e-c7a0-488c-84f6-5e4c1a1b5df012022-11-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-230LAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]28Current NDC, Legacy NDC, 5 package rows20231218_a9a4309e-fe43-4a26-a30f-c6577d650336.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSNa9a4309e-fe43-4a26-a30f-c6577d65033630
198428lamoTRIgine 150 MG Oral TabletPSNa9a4309e-fe43-4a26-a30f-c6577d65033630
198429lamoTRIgine 200 MG Oral TabletPSNa9a4309e-fe43-4a26-a30f-c6577d65033630
282401lamoTRIgine 25 MG Oral TabletPSNa9a4309e-fe43-4a26-a30f-c6577d65033630
198427lamotrigine 100 MG Oral TabletSCDa9a4309e-fe43-4a26-a30f-c6577d65033630
198428lamotrigine 150 MG Oral TabletSCDa9a4309e-fe43-4a26-a30f-c6577d65033630
198429lamotrigine 200 MG Oral TabletSCDa9a4309e-fe43-4a26-a30f-c6577d65033630
282401lamotrigine 25 MG Oral TabletSCDa9a4309e-fe43-4a26-a30f-c6577d65033630

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-230-0165862023001100 TABLET in 1 BOTTLE (65862-230-01) 100 tablet2009-01-270000-00-00NoNoCurrent
65862-230-106586202301010 in 1 BLISTER PACKHistorical
65862-230-606586202306060 TABLET in 1 BOTTLE (65862-230-60) 60 tablet2009-01-270000-00-00NoNoCurrent
65862-230-786586202307810 BLISTER PACK in 1 CARTON (65862-230-78) / 10 TABLET in 1 BLISTER PACK (65862-230-10) 10 blister pack2009-01-270000-00-00NoNoCurrent
65862-230-99658620230991000 TABLET in 1 BOTTLE (65862-230-99) 1000 tablet2009-01-270000-00-00NoNoCurrent