FDA.reportPublic FDA data

Lamotrigine

Product NDC
72888-025
11-digit product format
728880025
Labeler code
72888
Product ID
72888-025_43efd790-7e05-d37a-e063-6294a90a4156
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA078625
Marketing category
ANDA
Marketing start
2021-10-29
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
72888-025-00Lamotrigine1000 in 1 BOTTLETABLET10006
72888-025-01Lamotrigine100 in 1 BOTTLETABLET1006
72888-025-05Lamotrigine500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-025-00EA - Each72888-0257766eb13-9e74-4c07-a6e8-b8e3114776dd12022-12-07
72888-025-01EA - Each72888-025577061c1-25b7-4993-a7ba-fdf36338b52a12022-11-07
72888-025-05EA - Each72888-02546d2edf4-c89c-4298-9886-3073eaad920212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-025LAMOTRIGINE TABLET [ADVAGEN PHARMA LIMITED]3Current NDC, Legacy NDC, 3 package rows20230307_4ca9d713-ab63-48bf-9386-29301a842e60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN4ca9d713-ab63-48bf-9386-29301a842e606
198428lamoTRIgine 150 MG Oral TabletPSN4ca9d713-ab63-48bf-9386-29301a842e606
198429lamoTRIgine 200 MG Oral TabletPSN4ca9d713-ab63-48bf-9386-29301a842e606
282401lamoTRIgine 25 MG Oral TabletPSN4ca9d713-ab63-48bf-9386-29301a842e606
198427lamotrigine 100 MG Oral TabletSCD4ca9d713-ab63-48bf-9386-29301a842e606
198428lamotrigine 150 MG Oral TabletSCD4ca9d713-ab63-48bf-9386-29301a842e606
198429lamotrigine 200 MG Oral TabletSCD4ca9d713-ab63-48bf-9386-29301a842e606
282401lamotrigine 25 MG Oral TabletSCD4ca9d713-ab63-48bf-9386-29301a842e606

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-025-00728880025001000 TABLET in 1 BOTTLE (72888-025-00) 1000 tablet2021-10-290000-00-00NoNoCurrent
72888-025-0172888002501100 TABLET in 1 BOTTLE (72888-025-01) 100 tablet2021-10-290000-00-00NoNoCurrent
72888-025-0572888002505500 TABLET in 1 BOTTLE (72888-025-05) 500 tablet2021-10-290000-00-00NoNoCurrent