LAMOTRIGINE

Product NDC
13668-266
11-digit product format
136680266
Labeler code
13668
Product ID
13668-266_e20d1c8d-dadf-4a54-8f0c-4ce62087f2e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine
Dosage form
KIT
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA078947
Marketing category
ANDA
Marketing start
2009-01-27
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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui198427, 198428, 198429, 282401, 751139, 751563, 753451

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
13668-266-28LAMOTRIGINE14 in 1 PACKAGE, COMBINATIONKIT1426
13668-266-28LAMOTRIGINE1 in 1 BLISTER PACKKIT126
13668-266-99LAMOTRIGINE7 in 1 PACKAGE, COMBINATIONKIT726
13668-266-99LAMOTRIGINE1 in 1 BLISTER PACKKIT126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-266-28EA - Each13668-26671d02f0f-8a4a-4e21-9e23-c8589727bbd212015-10-02
13668-266-99EA - Each13668-2665484a5d7-5c3a-4f46-8304-93988151233012015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-266LAMOTRIGINE TABLET LAMOTRIGINE (LAMOTRIGINE) KIT [TORRENT PHARMACEUTICALS LIMITED]23Current NDC, Legacy NDC, 4 package rows20240830_3448839b-4933-4ef9-a80a-9e504d2c5696.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753451{14 (lamotrigine 100 MG Oral Tablet) / 84 (lamotrigine 25 MG Oral Tablet) } PackGPCK3448839b-4933-4ef9-a80a-9e504d2c569626
751139{35 (lamotrigine 25 MG Oral Tablet) } PackGPCK3448839b-4933-4ef9-a80a-9e504d2c569626
751563{7 (lamotrigine 100 MG Oral Tablet) / 42 (lamotrigine 25 MG Oral Tablet) } PackGPCK3448839b-4933-4ef9-a80a-9e504d2c569626
198427lamoTRIgine 100 MG Oral TabletPSN3448839b-4933-4ef9-a80a-9e504d2c569626
198428lamoTRIgine 150 MG Oral TabletPSN3448839b-4933-4ef9-a80a-9e504d2c569626
198429lamoTRIgine 200 MG Oral TabletPSN3448839b-4933-4ef9-a80a-9e504d2c569626
751563lamoTRIgine 25 MG (42), 100 MG (7) Oral Tablet 49 Count PackPSN3448839b-4933-4ef9-a80a-9e504d2c569626
753451lamoTRIgine 25 MG (84), 100 MG (14) Oral Tablet 98 Count PackPSN3448839b-4933-4ef9-a80a-9e504d2c569626
282401lamoTRIgine 25 MG Oral TabletPSN3448839b-4933-4ef9-a80a-9e504d2c569626
751139lamoTRIgine 25 MG Oral Tablet 35 Count PackPSN3448839b-4933-4ef9-a80a-9e504d2c569626
198427lamotrigine 100 MG Oral TabletSCD3448839b-4933-4ef9-a80a-9e504d2c569626
198428lamotrigine 150 MG Oral TabletSCD3448839b-4933-4ef9-a80a-9e504d2c569626
198429lamotrigine 200 MG Oral TabletSCD3448839b-4933-4ef9-a80a-9e504d2c569626
282401lamotrigine 25 MG Oral TabletSCD3448839b-4933-4ef9-a80a-9e504d2c569626
751139lamotrigine Blue (For Patients Taking Valproate)SY3448839b-4933-4ef9-a80a-9e504d2c569626
753451lamotrigine Green (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)SY3448839b-4933-4ef9-a80a-9e504d2c569626
751563lamotrigine Orange (USP Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)SY3448839b-4933-4ef9-a80a-9e504d2c569626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-266-281366802662814 BLISTER PACK in 1 PACKAGE, COMBINATION (13668-266-28) / 1 KIT in 1 BLISTER PACK14 blister pack2009-01-270000-00-00NoNoCurrent
13668-266-99136680266997 BLISTER PACK in 1 PACKAGE, COMBINATION (13668-266-99) / 1 KIT in 1 BLISTER PACK7 blister pack2009-01-270000-00-00NoNoCurrent