FDA.reportPublic FDA data

Lamotrigine

Product NDC
70518-1908
11-digit product format
705181908
Labeler code
70518
Product ID
70518-1908_498899e3-66a8-449a-e063-6394a90a026e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090170
Marketing category
ANDA
Marketing start
2019-02-25
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
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
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
70518-1908-0Lamotrigine30 in 1 BLISTER PACKTABLET3022
70518-1908-1Lamotrigine30 in 1 BLISTER PACKTABLET3022
70518-1908-2Lamotrigine30 in 1 BLISTER PACKTABLET3022
70518-1908-3Lamotrigine180 in 1 BOTTLE, PLASTICTABLET18022
70518-1908-4Lamotrigine30 in 1 BOTTLE, PLASTICTABLET3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1908LAMOTRIGINE TABLET [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 5 package rows20250507_1b5646a9-4724-44b8-8cd0-9c14f5e87f86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282401lamoTRIgine 25 MG Oral TabletPSN1b5646a9-4724-44b8-8cd0-9c14f5e87f8622
282401lamotrigine 25 MG Oral TabletSCD1b5646a9-4724-44b8-8cd0-9c14f5e87f8622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1908-07051819080030 TABLET in 1 BLISTER PACK (70518-1908-0) 30 tablet2019-02-250000-00-00NoNoCurrent
70518-1908-17051819080130 TABLET in 1 BLISTER PACK (70518-1908-1) 30 tablet2021-04-020000-00-00NoNoCurrent
70518-1908-27051819080230 TABLET in 1 BLISTER PACK (70518-1908-2) 30 tablet2021-11-290000-00-00NoNoCurrent
70518-1908-370518190803180 TABLET in 1 BOTTLE, PLASTIC (70518-1908-3) 180 tablet2022-01-150000-00-00NoNoCurrent
70518-1908-47051819080430 TABLET in 1 BOTTLE, PLASTIC (70518-1908-4) 30 tablet2024-04-10NoNoCurrent