FDA.reportPublic FDA data

Lamotrigine

Product NDC
62332-771
11-digit product format
623320771
Labeler code
62332
Product ID
62332-771_407283a4-871f-4f00-8b49-61129ef9a428
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA217278
Marketing category
ANDA
Marketing start
2026-03-02
Substance
LAMOTRIGINE
Active strength
50 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
LAMOTRIGINE50 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
62332-771-15Lamotrigine2 in 1 CARTONTABLET, ORALLY DISINTEGRATING24
62332-771-15Lamotrigine15 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING154
62332-771-30Lamotrigine30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSNdf34faa4-829e-413a-a230-cbec604eead94
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSNdf34faa4-829e-413a-a230-cbec604eead94
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSNdf34faa4-829e-413a-a230-cbec604eead94
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSNdf34faa4-829e-413a-a230-cbec604eead94
103968lamotrigine 100 MG Disintegrating Oral TabletSCDdf34faa4-829e-413a-a230-cbec604eead94
252479lamotrigine 200 MG Disintegrating Oral TabletSCDdf34faa4-829e-413a-a230-cbec604eead94
198430lamotrigine 25 MG Disintegrating Oral TabletSCDdf34faa4-829e-413a-a230-cbec604eead94
252478lamotrigine 50 MG Disintegrating Oral TabletSCDdf34faa4-829e-413a-a230-cbec604eead94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-771-15623320771152 BLISTER PACK in 1 CARTON (62332-771-15) / 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2026-03-02NoNoCurrent
62332-771-306233207713030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62332-771-30) 2026-03-02NoNoCurrent