FDA.reportPublic FDA data

Lamotrigine

Product NDC
65862-361
11-digit product format
658620361
Labeler code
65862
Product ID
65862-361_743955c4-0ece-4619-8e3e-a9e0a51e9491
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090401
Marketing category
ANDA
Marketing start
2009-11-04
Substance
LAMOTRIGINE
Active strength
5 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
2027-12-31
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
LAMOTRIGINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui311264, 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
65862-361-01Lamotrigine100 in 1 BOTTLETABLET, CHEWABLE10028
65862-361-05Lamotrigine500 in 1 BOTTLETABLET, CHEWABLE50028
65862-361-10Lamotrigine10 in 1 BLISTER PACKTABLET, CHEWABLE1028
65862-361-10Lamotrigine10 in 1 CARTONTABLET, CHEWABLE1028
65862-361-53Lamotrigine12000 in 1 BOTTLETABLET, CHEWABLE1200028
65862-361-99Lamotrigine1000 in 1 BOTTLETABLET, CHEWABLE100028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-361-01EA - Each65862-361ba5ca189-5eb8-46fa-bc64-a65c04e7231b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]15
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]15
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]15
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]15
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]15
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-361LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]25Current NDC, Legacy NDC, 6 package rows20231218_e08920c2-04a3-4fb5-acc5-0af3140f82e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311264lamoTRIgine 25 MG Tablet for Oral SuspensionPSNe08920c2-04a3-4fb5-acc5-0af3140f82e928
311265lamoTRIgine 5 MG Tablet for Oral SuspensionPSNe08920c2-04a3-4fb5-acc5-0af3140f82e928
311264lamotrigine 25 MG Tablet for Oral SuspensionSCDe08920c2-04a3-4fb5-acc5-0af3140f82e928
311265lamotrigine 5 MG Tablet for Oral SuspensionSCDe08920c2-04a3-4fb5-acc5-0af3140f82e928

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-361-0165862036101100 TABLET, CHEWABLE in 1 BOTTLE (65862-361-01) 2009-11-040000-00-00NoNoCurrent
65862-361-0565862036105500 TABLET, CHEWABLE in 1 BOTTLE (65862-361-05) 2009-11-040000-00-00NoNoCurrent
65862-361-106586203611010 BLISTER PACK in 1 CARTON (65862-361-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK10 blister pack2009-11-040000-00-00NoNoCurrent
65862-361-536586203615312000 TABLET, CHEWABLE in 1 BOTTLE (65862-361-53) 2009-11-040000-00-00NoNoCurrent
65862-361-99658620361991000 TABLET, CHEWABLE in 1 BOTTLE (65862-361-99) 2009-11-040000-00-00NoNoCurrent