FDA.reportPublic FDA data

Lamotrigine

Product NDC
27241-185
11-digit product format
272410185
Labeler code
27241
Product ID
27241-185_9791ac5c-7be4-4ff8-8de3-21ab21346ca9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA213271
Marketing category
ANDA
Marketing start
2021-01-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2026-12-31

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
27241-185-30Lamotrigine30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-185-30EA - Each27241-1859cb7c324-c956-4f1c-a392-70a8e2c4f60a12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-185LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [AJANTA PHARMA USA INC.]8Current NDC, Legacy NDC, 1 package rows20250306_9dfb5f87-0150-4c26-a89f-34f1ab389500.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSN9dfb5f87-0150-4c26-a89f-34f1ab38950010
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSN9dfb5f87-0150-4c26-a89f-34f1ab38950010
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSN9dfb5f87-0150-4c26-a89f-34f1ab38950010
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSN9dfb5f87-0150-4c26-a89f-34f1ab38950010
103968lamotrigine 100 MG Disintegrating Oral TabletSCD9dfb5f87-0150-4c26-a89f-34f1ab38950010
252479lamotrigine 200 MG Disintegrating Oral TabletSCD9dfb5f87-0150-4c26-a89f-34f1ab38950010
198430lamotrigine 25 MG Disintegrating Oral TabletSCD9dfb5f87-0150-4c26-a89f-34f1ab38950010
252478lamotrigine 50 MG Disintegrating Oral TabletSCD9dfb5f87-0150-4c26-a89f-34f1ab38950010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-185-302724101853030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-185-30) 2021-01-190000-00-00NoNoCurrent