FDA.reportPublic FDA data

Lamotrigine

Product NDC
51672-4130
11-digit product format
516724130
Labeler code
51672
Product ID
51672-4130_44812d3c-0fc0-67dd-e063-6394a90a9d70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078525
Marketing category
ANDA
Marketing start
2009-01-27
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, 282401

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
51672-4130-0Lamotrigine10 in 1 BLISTER PACKTABLET1021
51672-4130-0Lamotrigine10 in 1 CARTONTABLET1021
51672-4130-1Lamotrigine100 in 1 BOTTLETABLET10021
51672-4130-3Lamotrigine1000 in 1 BOTTLETABLET100021
51672-4130-4Lamotrigine60 in 1 BOTTLETABLET6021
51672-4130-6Lamotrigine30 in 1 BOTTLETABLET3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4130-1EA - Each51672-4130b1138f13-a1a8-4495-a8a5-2c4d49568df512012-07-24
51672-4130-3EA - Each51672-413033c9112c-59c4-4d89-834e-19e4d2ec823312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LamotrigineACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
LamotrigineACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
Aluminum OxideINACTIVE INGREDIENTLMI26O6933LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
crospovidoneINACTIVE INGREDIENT68401960MKLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
magnesium stearateINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
povidonesINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LamotrigineACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
LamotrigineACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
crospovidoneINACTIVE INGREDIENT68401960MKLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C Blue NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
magnesium stearateINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
povidoneINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4130LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]15Current NDC, Legacy NDC, 6 package rows20230517_b829f9b2-f0ac-408a-a6f4-18b72150227d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
198428lamoTRIgine 150 MG Oral TabletPSN7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
198429lamoTRIgine 200 MG Oral TabletPSN7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
282401lamoTRIgine 25 MG Oral TabletPSN2ea96dec-633c-4afb-9cd1-30861712be9f1
282401lamoTRIgine 25 MG Oral TabletPSN7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
198427lamotrigine 100 MG Oral TabletSCD7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
198428lamotrigine 150 MG Oral TabletSCD7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
198429lamotrigine 200 MG Oral TabletSCD7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
282401lamotrigine 25 MG Oral TabletSCD2ea96dec-633c-4afb-9cd1-30861712be9f1
282401lamotrigine 25 MG Oral TabletSCD7332e0ea-fbd0-43fb-8d1e-f7068504c61d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4130-05167241300010 BLISTER PACK in 1 CARTON (51672-4130-0) / 10 TABLET in 1 BLISTER PACK10 blister pack2009-01-270000-00-00NoNoCurrent
51672-4130-151672413001100 TABLET in 1 BOTTLE (51672-4130-1) 100 tablet2009-01-270000-00-00NoNoCurrent
51672-4130-3516724130031000 TABLET in 1 BOTTLE (51672-4130-3) 1000 tablet2009-01-270000-00-00NoNoCurrent
51672-4130-45167241300460 TABLET in 1 BOTTLE (51672-4130-4) 60 tablet2009-01-270000-00-00NoNoCurrent
51672-4130-65167241300630 TABLET in 1 BOTTLE (51672-4130-6) 30 tablet2009-01-270000-00-00NoNoCurrent