FDA.reportPublic FDA data

Lamotrigine

Product NDC
80425-0289
11-digit product format
804250289
Labeler code
80425
Product ID
80425-0289_2a9b9724-0258-e829-e063-6394a90a1c07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA090170
Marketing category
ANDA
Marketing start
2023-03-24
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
Rxcui282401

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
80425-0289-1Lamotrigine30 in 1 BOTTLETABLET302
80425-0289-2Lamotrigine60 in 1 BOTTLETABLET602
80425-0289-3Lamotrigine90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0289-1EA - Each80425-0289902fd383-e045-4a04-90d7-c3bbdb9daed712023-04-07
80425-0289-2EA - Each80425-0289ad005172-4479-47ce-9e8b-01da723d13c112023-04-07
80425-0289-3EA - Each80425-0289cf9f90dc-57c1-4142-8119-8d5139a8e74412023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0289LAMOTRIGINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f7a86237-ece4-7cc4-e053-6294a90a1308.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282401lamoTRIgine 25 MG Oral TabletPSNf7a86237-ece4-7cc4-e053-6294a90a13082
282401lamotrigine 25 MG Oral TabletSCDf7a86237-ece4-7cc4-e053-6294a90a13082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0289-18042502890130 TABLET in 1 BOTTLE (80425-0289-1) 30 tablet2023-03-24NoNoCurrent
80425-0289-28042502890260 TABLET in 1 BOTTLE (80425-0289-2) 60 tablet2023-03-24NoNoCurrent
80425-0289-38042502890390 TABLET in 1 BOTTLE (80425-0289-3) 90 tablet2023-03-24NoNoCurrent