FDA.reportPublic FDA data

Lamotrigine

Product NDC
13668-341
11-digit product format
136680341
Labeler code
13668
Product ID
13668-341_aae9e98a-c9b3-4e3c-8e24-ff46f11bcadf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA203370
Marketing category
ANDA
Marketing start
2013-12-23
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
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
LAMOTRIGINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui850087, 850091, 900156, 900164

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-341-01Lamotrigine100 in 1 BOTTLETABLET, EXTENDED RELEASE10019
13668-341-05Lamotrigine500 in 1 BOTTLETABLET, EXTENDED RELEASE50019
13668-341-30Lamotrigine30 in 1 BOTTLETABLET, EXTENDED RELEASE3019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-341-30EA - Each13668-341365f5bda-8c61-48e0-b7d7-8e2ca368b81a12018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFLAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LLAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-341LAMOTRIGINE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]16Current NDC, Legacy NDC, 3 package rows20241017_52df02a7-83da-4b20-9951-69790237dc24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSN52df02a7-83da-4b20-9951-69790237dc2419
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSN52df02a7-83da-4b20-9951-69790237dc2419
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSN52df02a7-83da-4b20-9951-69790237dc2419
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSN52df02a7-83da-4b20-9951-69790237dc2419
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCD52df02a7-83da-4b20-9951-69790237dc2419
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCD52df02a7-83da-4b20-9951-69790237dc2419
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCD52df02a7-83da-4b20-9951-69790237dc2419
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCD52df02a7-83da-4b20-9951-69790237dc2419
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSY52df02a7-83da-4b20-9951-69790237dc2419
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSY52df02a7-83da-4b20-9951-69790237dc2419
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSY52df02a7-83da-4b20-9951-69790237dc2419
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSY52df02a7-83da-4b20-9951-69790237dc2419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-341-0113668034101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-01) 2013-12-230000-00-00NoNoCurrent
13668-341-0513668034105500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-05) 2013-12-230000-00-00NoNoCurrent
13668-341-301366803413030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-30) 2013-12-230000-00-00NoNoCurrent
13668-341-7413668034174100 TABLET, EXTENDED RELEASE in 1 CARTON (13668-341-74) 2013-12-230000-00-00NoNoCurrent