FDA.reportPublic FDA data

lamotrigine

Product NDC
62332-095
11-digit product format
623320095
Labeler code
62332
Product ID
62332-095_8b09deb8-500f-428a-b588-6a238c7c553c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA201168
Marketing category
ANDA
Marketing start
2014-04-11
Substance
LAMOTRIGINE
Active strength
5 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
LAMOTRIGINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui311264, 311265

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
62332-095-30lamotrigine30 in 1 BOTTLETABLET, FOR SUSPENSION3030
62332-095-31lamotrigine100 in 1 BOTTLETABLET, FOR SUSPENSION10030
62332-095-91lamotrigine1000 in 1 BOTTLETABLET, FOR SUSPENSION100030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-095-31EA - Each62332-0954e21316c-8b56-4d95-b1a7-b4c0fb58de1012016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-095LAMOTRIGINE TABLET, FOR SUSPENSION [ALEMBIC PHARMACEUTICALS INC.]27Current NDC, Legacy NDC, 3 package rows20211020_05cba628-b12c-44d8-89a8-3522fe417cc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311264lamoTRIgine 25 MG Tablet for Oral SuspensionPSN05cba628-b12c-44d8-89a8-3522fe417cc130
311265lamoTRIgine 5 MG Tablet for Oral SuspensionPSN05cba628-b12c-44d8-89a8-3522fe417cc130
311264lamotrigine 25 MG Tablet for Oral SuspensionSCD05cba628-b12c-44d8-89a8-3522fe417cc130
311265lamotrigine 5 MG Tablet for Oral SuspensionSCD05cba628-b12c-44d8-89a8-3522fe417cc130

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-095-306233200953030 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-30) 2014-04-110000-00-00NoNoCurrent
62332-095-3162332009531100 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-31) 2014-04-110000-00-00NoNoCurrent
62332-095-91623320095911000 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-91) 2014-04-110000-00-00NoNoCurrent