FDA.reportPublic FDA data

Lamotrigine

Product NDC
0228-1638
11-digit product format
002281638
Labeler code
0228
Product ID
0228-1638_49ac5dcd-9ccd-4e5a-9fdd-fe22a79c2770
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA200672
Marketing category
ANDA
Marketing start
2016-06-01
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
Rxcui850087, 850091, 900156, 900164, 1098608, 1146690

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-1638-03Lamotrigine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-1638-03EA - Each0228-16380085111a-8594-4332-b053-a8cadc271ab812017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-1638LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]24Current NDC, Legacy NDC, 1 package rows20250523_87beaf22-593d-4170-bb58-332c615ef90d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSN87beaf22-593d-4170-bb58-332c615ef90d28
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSN87beaf22-593d-4170-bb58-332c615ef90d28
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSN87beaf22-593d-4170-bb58-332c615ef90d28
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSN87beaf22-593d-4170-bb58-332c615ef90d28
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSN87beaf22-593d-4170-bb58-332c615ef90d28
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSN87beaf22-593d-4170-bb58-332c615ef90d28
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCD87beaf22-593d-4170-bb58-332c615ef90d28
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCD87beaf22-593d-4170-bb58-332c615ef90d28
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCD87beaf22-593d-4170-bb58-332c615ef90d28
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCD87beaf22-593d-4170-bb58-332c615ef90d28
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCD87beaf22-593d-4170-bb58-332c615ef90d28
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCD87beaf22-593d-4170-bb58-332c615ef90d28
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSY87beaf22-593d-4170-bb58-332c615ef90d28
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSY87beaf22-593d-4170-bb58-332c615ef90d28
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSY87beaf22-593d-4170-bb58-332c615ef90d28
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSY87beaf22-593d-4170-bb58-332c615ef90d28
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSY87beaf22-593d-4170-bb58-332c615ef90d28
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSY87beaf22-593d-4170-bb58-332c615ef90d28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-1638-030022816380330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1638-03) 2016-06-010000-00-00NoNoCurrent