FDA.reportPublic FDA data

Lamotrigine

Product NDC
50090-2825
11-digit product format
500902825
Labeler code
50090
Product ID
50090-2825_05296bf5-17d9-4ecc-8ab5-c1176c991ae9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077633
Marketing category
ANDA
Marketing start
2009-01-27
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
25 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
2019-12-31
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
50090-2825-02020-01-31C16284748780-19d75b9d0-ab13-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE) safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE). LAMOTRIGINE tablets, for oral use LAMOTRIGINE tablets (chewable, dispersible), for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2825-0Lamotrigine1 in 1 BLISTER PACKTABLET18
50090-2825-0Lamotrigine33 in 1 BOX, UNIT-DOSETABLET338

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2825-0EA - Each50090-28257b3a7be9-fbd9-4a56-a32b-9f34f5c7503812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2825LAMOTRIGINE TABLET [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20190225_fda0e8a5-4410-409f-807a-876738a5fc1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282401lamoTRIgine 25 MG Oral TabletPSNfda0e8a5-4410-409f-807a-876738a5fc1f8
282401lamotrigine 25 MG Oral TabletSCDfda0e8a5-4410-409f-807a-876738a5fc1f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2825-0500902825001 in 1 BLISTER PACKHistorical