FDA.reportPublic FDA data

Lamotrigine Extended Release

Product NDC
52817-242
11-digit product format
528170242
Labeler code
52817
Product ID
52817-242_9f02e5fb-2921-5bc7-e053-2a95a90ae9e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine extended release
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA202887
Marketing category
ANDA
Marketing start
2017-06-05
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
52817-242-302023-01-30C16284748780-1f386c649-dc39-0266-e053-dadaa90a7c1aThese 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
52817-242-30Lamotrigine Extended Release30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-242-30EA - Each52817-242ef3d39dd-bb64-4355-92b9-a6d32960f45812017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-242LAMOTRIGINE EXTENDED RELEASE TABLET [TRUPHARMA, LLC]3Legacy NDC, 1 package rows20200221_9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSN9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSN9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSN9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSN9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCD9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCD9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCD9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCD9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSY9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSY9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSY9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSY9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-242-305281702423030 TABLET in 1 BOTTLE (52817-242-30) 30 tablet2017-06-050000-00-00NoNoCurrent