FDA.reportPublic FDA data

lamotrigine

Product NDC
69117-0044
11-digit product format
691170044
Labeler code
69117
Product ID
69117-0044_47239426-3d75-73d8-e063-6294a90a608d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine extended-release
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Yiling Pharmaceutical, Inc.
Application
ANDA213949
Marketing category
ANDA
Marketing start
2021-12-09
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
2026-12-31
Current FDA listing
Yes

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
69117-0044-12024-12-30C16284748780-11030e365-1c40-111a-e063-dadaa90a10e2LAMOTRIGINE extended-release tablets Yiling pharmaceutical Ltd ------------------------------------------------------------- These 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
69117-0044-22024-12-30C16284748780-11030e365-1c40-111a-e063-dadaa90a10e2LAMOTRIGINE extended-release tablets Yiling pharmaceutical Ltd ------------------------------------------------------------- These 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
69117-0044-32024-12-30C16284748780-11030e365-1c40-111a-e063-dadaa90a10e2LAMOTRIGINE extended-release tablets Yiling pharmaceutical Ltd ------------------------------------------------------------- These 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
69117-0044-12024-01-30C16284748780-11030e365-1c40-111a-e063-dadaa90a10e2LAMOTRIGINE extended-release tablets Yiling pharmaceutical Ltd ------------------------------------------------------------- These 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
69117-0044-22024-01-30C16284748780-11030e365-1c40-111a-e063-dadaa90a10e2LAMOTRIGINE extended-release tablets Yiling pharmaceutical Ltd ------------------------------------------------------------- These 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
69117-0044-32024-01-30C16284748780-11030e365-1c40-111a-e063-dadaa90a10e2LAMOTRIGINE extended-release tablets Yiling pharmaceutical Ltd ------------------------------------------------------------- These 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
69117-0044-1lamotrigine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE307
69117-0044-2lamotrigine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1007
69117-0044-3lamotrigine500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0044LAMOTRIGINE (LAMOTRIGINE EXTENDED-RELEASE) TABLET, FILM COATED, EXTENDED RELEASE [YILING PHARMACEUTICAL, INC.]6Current NDC, Legacy NDC, 3 package rows20250101_f7de11a5-5357-4753-b1ac-b15123b50028.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSNf7de11a5-5357-4753-b1ac-b15123b500287
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSNf7de11a5-5357-4753-b1ac-b15123b500287
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSNf7de11a5-5357-4753-b1ac-b15123b500287
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSNf7de11a5-5357-4753-b1ac-b15123b500287
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSNf7de11a5-5357-4753-b1ac-b15123b500287
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSNf7de11a5-5357-4753-b1ac-b15123b500287
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCDf7de11a5-5357-4753-b1ac-b15123b500287
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCDf7de11a5-5357-4753-b1ac-b15123b500287
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCDf7de11a5-5357-4753-b1ac-b15123b500287
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCDf7de11a5-5357-4753-b1ac-b15123b500287
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCDf7de11a5-5357-4753-b1ac-b15123b500287
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCDf7de11a5-5357-4753-b1ac-b15123b500287
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSYf7de11a5-5357-4753-b1ac-b15123b500287
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSYf7de11a5-5357-4753-b1ac-b15123b500287
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSYf7de11a5-5357-4753-b1ac-b15123b500287
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSYf7de11a5-5357-4753-b1ac-b15123b500287
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSYf7de11a5-5357-4753-b1ac-b15123b500287
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSYf7de11a5-5357-4753-b1ac-b15123b500287

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69117-0044-16911700440130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0044-1) 2021-12-090000-00-00NoNoCurrent
69117-0044-269117004402100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0044-2) 2021-12-090000-00-00NoNoCurrent
69117-0044-369117004403500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0044-3) 2021-12-090000-00-00NoNoCurrent