FDA.reportPublic FDA data

Lamotrigine Extended Release

Product NDC
63629-7020
11-digit product format
636297020
Labeler code
63629
Product ID
63629-7020_b6acfef1-7d89-495a-a642-a47cc7d31e47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine extended release
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201791
Marketing category
ANDA
Marketing start
2013-01-18
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
63629-7020-12024-01-30C16284748780-19d75b9d0-8311-f424-e053-dadaa90a57ceThese 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
63629-7020-12020-10-16C16284748780-19d75b9d0-8311-f424-e053-dadaa90a57ceThese 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
63629-7020-12020-01-31C16284748780-19d75b9d0-8311-f424-e053-dadaa90a57ceThese 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
63629-7020-1Lamotrigine Extended Release30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7020LAMOTRIGINE EXTENDED RELEASE TABLET [BRYANT RANCH PREPACK]4Legacy NDC, 1 package rows20220115_b6acfef1-7d89-495a-a642-a47cc7d31e47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSNb6acfef1-7d89-495a-a642-a47cc7d31e474
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCDb6acfef1-7d89-495a-a642-a47cc7d31e474
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSYb6acfef1-7d89-495a-a642-a47cc7d31e474

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7020-16362970200130 TABLET in 1 BOTTLE (63629-7020-1) 30 tablet2016-06-070000-00-00NoNoCurrent