FDA.reportPublic FDA data

Lamotrigine

Product NDC
50090-2131
11-digit product format
500902131
Labeler code
50090
Product ID
50090-2131_a2a8622a-6df4-4c7e-b026-fd5080a9196a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090170
Marketing category
ANDA
Marketing start
2011-11-01
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
Rxcui198427, 198428, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2131-02023-02-07C16284748780-1f386c649-b574-0266-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
50090-2131-12023-02-07C16284748780-1f386c649-b574-0266-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
50090-2131-02023-01-30C16284748780-1f386c649-b574-0266-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
50090-2131-12023-01-30C16284748780-1f386c649-b574-0266-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
50090-2131-0Lamotrigine60 in 1 BOTTLETABLET6028
50090-2131-1Lamotrigine30 in 1 BOTTLETABLET3028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2131-0EA - Each50090-213131d7c0cb-fc6d-4e38-a753-e9d8d502c2d112019-02-13
50090-2131-1EA - Each50090-213183748fbd-25b8-4158-8886-57d00423b14112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2131LAMOTRIGINE TABLET [A-S MEDICATION SOLUTIONS]25Current NDC, Legacy NDC, 2 package rows20240824_6139a858-700c-4eb9-9f84-99d280bde326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN6139a858-700c-4eb9-9f84-99d280bde32628
198428lamoTRIgine 150 MG Oral TabletPSN6139a858-700c-4eb9-9f84-99d280bde32628
282401lamoTRIgine 25 MG Oral TabletPSN6139a858-700c-4eb9-9f84-99d280bde32628
198427lamotrigine 100 MG Oral TabletSCD6139a858-700c-4eb9-9f84-99d280bde32628
198428lamotrigine 150 MG Oral TabletSCD6139a858-700c-4eb9-9f84-99d280bde32628
282401lamotrigine 25 MG Oral TabletSCD6139a858-700c-4eb9-9f84-99d280bde32628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2131-05009021310060 TABLET in 1 BOTTLE (50090-2131-0) 60 tablet2015-10-150000-00-00NoNoCurrent
50090-2131-15009021310130 TABLET in 1 BOTTLE (50090-2131-1) 30 tablet2020-01-210000-00-00NoNoCurrent