FDA.reportPublic FDA data

Lamotrigine

Product NDC
65162-988
11-digit product format
651620988
Labeler code
65162
Product ID
65162-988_40e5eebb-7577-4c9e-bf1d-f511b8cb4d33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207497
Marketing category
ANDA
Marketing start
2018-11-30
Substance
LAMOTRIGINE
Active strength
250 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
LAMOTRIGINE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui850087, 850091, 900156, 900164, 1098608, 1146690

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-988-032024-06-07C16284748780-11030e364-f985-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LAMOTRIGINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE EXTENDED-RELEASE TABLETS. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
65162-988-092024-06-07C16284748780-11030e364-f985-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LAMOTRIGINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE EXTENDED-RELEASE TABLETS. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
65162-988-032024-01-30C16284748780-11030e364-f985-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LAMOTRIGINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE EXTENDED-RELEASE TABLETS. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
65162-988-092024-01-30C16284748780-11030e364-f985-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LAMOTRIGINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE EXTENDED-RELEASE TABLETS. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-988-03Lamotrigine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3019
65162-988-09Lamotrigine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-988-03EA - Each65162-988d6826ebf-50e9-4690-a3ed-eeba6a2e997412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-988LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]17Current NDC, Legacy NDC, 2 package rows20250116_0833d3df-2df1-4abd-abe0-7fb2c0253c80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSN0833d3df-2df1-4abd-abe0-7fb2c0253c8019
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSN0833d3df-2df1-4abd-abe0-7fb2c0253c8019
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSN0833d3df-2df1-4abd-abe0-7fb2c0253c8019
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSN0833d3df-2df1-4abd-abe0-7fb2c0253c8019
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSN0833d3df-2df1-4abd-abe0-7fb2c0253c8019
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSN0833d3df-2df1-4abd-abe0-7fb2c0253c8019
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCD0833d3df-2df1-4abd-abe0-7fb2c0253c8019
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCD0833d3df-2df1-4abd-abe0-7fb2c0253c8019
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCD0833d3df-2df1-4abd-abe0-7fb2c0253c8019
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCD0833d3df-2df1-4abd-abe0-7fb2c0253c8019
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCD0833d3df-2df1-4abd-abe0-7fb2c0253c8019
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCD0833d3df-2df1-4abd-abe0-7fb2c0253c8019
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSY0833d3df-2df1-4abd-abe0-7fb2c0253c8019
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSY0833d3df-2df1-4abd-abe0-7fb2c0253c8019
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSY0833d3df-2df1-4abd-abe0-7fb2c0253c8019
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSY0833d3df-2df1-4abd-abe0-7fb2c0253c8019
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSY0833d3df-2df1-4abd-abe0-7fb2c0253c8019
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSY0833d3df-2df1-4abd-abe0-7fb2c0253c8019
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-988-036516209880330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-988-03) 2018-11-300000-00-00NoNoCurrent
65162-988-096516209880990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-988-09) 2018-11-300000-00-00NoNoCurrent