FDA.reportPublic FDA data

Lamotrigine

Product NDC
0115-9941
11-digit product format
001159941
Labeler code
0115
Product ID
0115-9941_813e9f35-df9e-428a-9f4f-1a312c86f937
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA200828
Marketing category
ANDA
Marketing start
2018-12-27
Substance
LAMOTRIGINE
Active strength
100 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
LAMOTRIGINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui103968, 198430, 252478, 252479

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
0115-9941-082024-09-19C16284748780-1ab0e2407-2b93-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
0115-9941-082023-01-30C16284748780-1ab0e2407-2b93-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
0115-9941-082020-11-24C16284748780-1ab0e2407-2b93-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
0115-9941-082020-09-27C16284748780-1ab0e2407-2b93-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
0115-9941-082020-09-25C16284748780-1ab0e2407-2b93-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
0115-9941-082020-07-22C16284748780-1ab0e2407-2b93-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-9941-01Lamotrigine30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-9941-01EA - Each0115-9941eed1c424-8316-4298-a85f-74d14336b52612025-02-10
0115-9941-08EA - Each0115-99411f4a0287-3f5a-40c3-b82d-a4d72fa8f32c12019-05-02
0115-9941-15EA - Each0115-994139ab02e6-da77-4349-b736-87f1854f369c12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-9941LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]12Current NDC, Legacy NDC, 1 package rows20241024_9e5c2d76-47a6-4a57-b23c-2398b307380c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSN9e5c2d76-47a6-4a57-b23c-2398b307380c14
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSN9e5c2d76-47a6-4a57-b23c-2398b307380c14
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSN9e5c2d76-47a6-4a57-b23c-2398b307380c14
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSN9e5c2d76-47a6-4a57-b23c-2398b307380c14
103968lamotrigine 100 MG Disintegrating Oral TabletSCD9e5c2d76-47a6-4a57-b23c-2398b307380c14
252479lamotrigine 200 MG Disintegrating Oral TabletSCD9e5c2d76-47a6-4a57-b23c-2398b307380c14
198430lamotrigine 25 MG Disintegrating Oral TabletSCD9e5c2d76-47a6-4a57-b23c-2398b307380c14
252478lamotrigine 50 MG Disintegrating Oral TabletSCD9e5c2d76-47a6-4a57-b23c-2398b307380c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-9941-010011599410130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0115-9941-01) 2024-09-20NoNoHistorical
0115-9941-08001159941083 BLISTER PACK in 1 CARTON (0115-9941-08) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-9941-15) 3 blister pack2018-12-270000-00-00NoNoCurrent