FDA.reportPublic FDA data

LAMOTRIGINE

Product NDC
43063-238
11-digit product format
430630238
Labeler code
43063
Product ID
43063-238_508ca78d-d94e-a8b9-e063-6394a90a52a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078947
Marketing category
ANDA
Marketing start
2009-01-27
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
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
LAMOTRIGINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui282401

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
43063-238-30LAMOTRIGINE30 in 1 BOTTLE, PLASTICTABLET3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-238-30EA - Each43063-2380e7cf339-56d5-419e-ba48-46c006389d1612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE (LAMOTRIGINE ) TABLET [PD-RX PHARMACEUTICALS, INC.]4
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE (LAMOTRIGINE ) TABLET [PD-RX PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-238LAMOTRIGINE TABLET [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 1 package rows20240922_c638ab70-05dd-4f8b-9a11-b33a75f8c504.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282401lamoTRIgine 25 MG Oral TabletPSNc638ab70-05dd-4f8b-9a11-b33a75f8c50426
282401lamotrigine 25 MG Oral TabletSCDc638ab70-05dd-4f8b-9a11-b33a75f8c50426

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-238-304306302383030 TABLET in 1 BOTTLE, PLASTIC (43063-238-30) 30 tablet2014-06-280000-00-00NoNoCurrent