FDA.reportPublic FDA data

Lamotrigine

Product NDC
42291-445
11-digit product format
422910445
Labeler code
42291
Product ID
42291-445_485d3fe4-eadb-a4dc-e063-6294a90ab9f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA207497
Marketing category
ANDA
Marketing start
2020-05-22
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
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
LAMOTRIGINE100 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
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-445-30Lamotrigine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-445LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE [AVKARE]3Current NDC, Legacy NDC, 1 package rows20240110_a63e19c0-a093-e896-e053-2a95a90a7ccd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSNa63e19c0-a093-e896-e053-2a95a90a7ccd4
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCDa63e19c0-a093-e896-e053-2a95a90a7ccd4
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSYa63e19c0-a093-e896-e053-2a95a90a7ccd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-445-304229104453030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-445-30) 2020-05-220000-00-00NoNoCurrent