FDA.reportPublic FDA data

Lamotrigine

Product NDC
43598-552
11-digit product format
435980552
Labeler code
43598
Product ID
43598-552_8da9fd8c-e302-4475-bc54-3168d01b56c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Dr. Reddy�s Laboratories Inc.
Application
ANDA206382
Marketing category
ANDA
Marketing start
2016-06-17
Substance
LAMOTRIGINE
Active strength
100 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui103968, 198430, 252478, 252479

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-552-30Lamotrigine30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-552-30EA - Each43598-55264def58b-29f3-4212-b091-7f2e1457847a12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-552LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [DR. REDDY’S LABORATORIES INC.]6Current NDC, Legacy NDC, 1 package rows20221104_54ea1ec3-876b-4d3a-a92b-1a6d70951de0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSN54ea1ec3-876b-4d3a-a92b-1a6d70951de08
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSN54ea1ec3-876b-4d3a-a92b-1a6d70951de08
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSN54ea1ec3-876b-4d3a-a92b-1a6d70951de08
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSN54ea1ec3-876b-4d3a-a92b-1a6d70951de08
103968lamotrigine 100 MG Disintegrating Oral TabletSCD54ea1ec3-876b-4d3a-a92b-1a6d70951de08
252479lamotrigine 200 MG Disintegrating Oral TabletSCD54ea1ec3-876b-4d3a-a92b-1a6d70951de08
198430lamotrigine 25 MG Disintegrating Oral TabletSCD54ea1ec3-876b-4d3a-a92b-1a6d70951de08
252478lamotrigine 50 MG Disintegrating Oral TabletSCD54ea1ec3-876b-4d3a-a92b-1a6d70951de08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-552-304359805523030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43598-552-30) 2016-06-170000-00-00NoNoCurrent