FDA.reportPublic FDA data

Lamotrigine

Product NDC
62332-418
11-digit product format
623320418
Labeler code
62332
Product ID
62332-418_e0d81ac2-c195-4adb-a249-43befe697ee6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211821
Marketing category
ANDA
Marketing start
2024-10-07
Substance
LAMOTRIGINE
Active strength
250 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
LAMOTRIGINE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui900156, 1098608, 1146690

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
62332-418-30Lamotrigine30 in 1 BOTTLETABLET, EXTENDED RELEASE307
62332-418-91Lamotrigine1000 in 1 BOTTLETABLET, EXTENDED RELEASE10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-418LAMOTRIGINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS INC.]6Current NDC, 2 package rows20241011_4bd7193f-a81a-4909-90c2-7f324fc6ddfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSN4bd7193f-a81a-4909-90c2-7f324fc6ddfd7
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSN4bd7193f-a81a-4909-90c2-7f324fc6ddfd7
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSN4bd7193f-a81a-4909-90c2-7f324fc6ddfd7
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCD4bd7193f-a81a-4909-90c2-7f324fc6ddfd7
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCD4bd7193f-a81a-4909-90c2-7f324fc6ddfd7
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCD4bd7193f-a81a-4909-90c2-7f324fc6ddfd7
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSY4bd7193f-a81a-4909-90c2-7f324fc6ddfd7
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSY4bd7193f-a81a-4909-90c2-7f324fc6ddfd7
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSY4bd7193f-a81a-4909-90c2-7f324fc6ddfd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-418-306233204183030 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-418-30) 2024-10-07NoNoCurrent
62332-418-91623320418911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-418-91) 2024-10-07NoNoCurrent