FDA.reportPublic FDA data

LAMOTRIGINE

Product NDC
51672-4254
11-digit product format
516724254
Labeler code
51672
Product ID
51672-4254_5087f34d-ca4f-86c8-e063-6294a90a08ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA219677
Marketing category
ANDA
Marketing start
2026-03-01
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
51672-4254-6LAMOTRIGINE30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4254-6EA - Each51672-425478fc92dd-437e-4176-9e20-94e623a5e83412026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSN83297e2e-9199-4b3d-9f44-a921787758fe7
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSN83297e2e-9199-4b3d-9f44-a921787758fe7
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSN83297e2e-9199-4b3d-9f44-a921787758fe7
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSN83297e2e-9199-4b3d-9f44-a921787758fe7
103968lamotrigine 100 MG Disintegrating Oral TabletSCD83297e2e-9199-4b3d-9f44-a921787758fe7
252479lamotrigine 200 MG Disintegrating Oral TabletSCD83297e2e-9199-4b3d-9f44-a921787758fe7
198430lamotrigine 25 MG Disintegrating Oral TabletSCD83297e2e-9199-4b3d-9f44-a921787758fe7
252478lamotrigine 50 MG Disintegrating Oral TabletSCD83297e2e-9199-4b3d-9f44-a921787758fe7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-4254-65167242540630 TABLET in 1 BOTTLE (51672-4254-6) 30 tablet2026-03-01NoNoHistorical