FDA.reportPublic FDA data

LAMOTRIGINE

Product NDC
13668-696
11-digit product format
136680696
Labeler code
13668
Product ID
13668-696_1a7c93f4-7ede-4574-b2f5-5d01dc87cdf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA217100
Marketing category
ANDA
Marketing start
2026-01-08
Substance
LAMOTRIGINE
Active strength
200 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
LAMOTRIGINE200 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-696-01LAMOTRIGINE100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1005
13668-696-30LAMOTRIGINE30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING305
13668-696-71LAMOTRIGINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING105
13668-696-72LAMOTRIGINE30 in 1 CARTONTABLET, ORALLY DISINTEGRATING305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-696-30EA - Each13668-69616bcdc45-7584-47f1-a15d-ecf28aa9191312026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSN22225cc4-028e-43ad-8e1f-dcebdc244ecb5
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSN22225cc4-028e-43ad-8e1f-dcebdc244ecb5
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSN22225cc4-028e-43ad-8e1f-dcebdc244ecb5
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSN22225cc4-028e-43ad-8e1f-dcebdc244ecb5
103968lamotrigine 100 MG Disintegrating Oral TabletSCD22225cc4-028e-43ad-8e1f-dcebdc244ecb5
252479lamotrigine 200 MG Disintegrating Oral TabletSCD22225cc4-028e-43ad-8e1f-dcebdc244ecb5
198430lamotrigine 25 MG Disintegrating Oral TabletSCD22225cc4-028e-43ad-8e1f-dcebdc244ecb5
252478lamotrigine 50 MG Disintegrating Oral TabletSCD22225cc4-028e-43ad-8e1f-dcebdc244ecb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-696-0113668069601100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-696-01) 2026-01-08NoNoHistorical
13668-696-301366806963030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-696-30) 2026-01-08NoNoHistorical
13668-696-711366806967110 in 1 BLISTER PACKHistorical
13668-696-721366806967230 BLISTER PACK in 1 CARTON (13668-696-72) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (13668-696-71) 30 blister pack2026-01-08NoNoHistorical