FDA.reportPublic FDA data

Lamotrigine

Product NDC
70518-2577
11-digit product format
705182577
Labeler code
70518
Product ID
70518-2577_4a691256-f3b1-2c1a-e063-6294a90ab777
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090170
Marketing category
ANDA
Marketing start
2020-02-14
Substance
LAMOTRIGINE
Active strength
150 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
LAMOTRIGINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui198428

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2577-02023-03-10C16284748780-1f386c64a-0f4e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
70518-2577-02023-03-10C16284748780-1f386c64a-0f4e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
70518-2577-02023-01-30C16284748780-1f386c64a-0f4e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
70518-2577-02023-01-30C16284748780-1f386c64a-0f4e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2577-0Lamotrigine30 in 1 BOXTABLET308
70518-2577-1Lamotrigine1 in 1 POUCHTABLET18
70518-2577-2Lamotrigine30 in 1 BOTTLE, PLASTICTABLET308

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198428lamoTRIgine 150 MG Oral TabletPSNd1691a60-ff0a-4755-b445-1d78309d5af08
198428lamotrigine 150 MG Oral TabletSCDd1691a60-ff0a-4755-b445-1d78309d5af08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2577-07051825770030 POUCH in 1 BOX (70518-2577-0) > 1 TABLET in 1 POUCH (70518-2577-1) 30 pouch2020-02-140000-00-00NoNoCurrent
70518-2577-1705182577011 in 1 POUCHHistorical
70518-2577-27051825770230 TABLET in 1 BOTTLE, PLASTIC (70518-2577-2) 30 tablet2025-06-01NoNoHistorical