FDA.reportPublic FDA data

Lamotrigine

Product NDC
16714-626
11-digit product format
167140626
Labeler code
16714
Product ID
16714-626_9c4867cc-d291-bb7a-2942-69dab9cede75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA202383
Marketing category
ANDA
Marketing start
2017-06-20
Substance
LAMOTRIGINE
Active strength
200 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
LAMOTRIGINE200 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
16714-626-01Lamotrigine30 in 1 BOTTLETABLET, EXTENDED RELEASE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-626-01EA - Each16714-626208ff110-6eed-4e67-bea8-90537b21c23712017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-626LAMOTRIGINE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC]7Current NDC, Legacy NDC, 1 package rows20231227_9ab07d6b-ae4a-a310-5572-b266676cd29e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSN9ab07d6b-ae4a-a310-5572-b266676cd29e8
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSN9ab07d6b-ae4a-a310-5572-b266676cd29e8
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSN9ab07d6b-ae4a-a310-5572-b266676cd29e8
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSN9ab07d6b-ae4a-a310-5572-b266676cd29e8
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSN9ab07d6b-ae4a-a310-5572-b266676cd29e8
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSN9ab07d6b-ae4a-a310-5572-b266676cd29e8
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCD9ab07d6b-ae4a-a310-5572-b266676cd29e8
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCD9ab07d6b-ae4a-a310-5572-b266676cd29e8
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCD9ab07d6b-ae4a-a310-5572-b266676cd29e8
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCD9ab07d6b-ae4a-a310-5572-b266676cd29e8
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCD9ab07d6b-ae4a-a310-5572-b266676cd29e8
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCD9ab07d6b-ae4a-a310-5572-b266676cd29e8
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSY9ab07d6b-ae4a-a310-5572-b266676cd29e8
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSY9ab07d6b-ae4a-a310-5572-b266676cd29e8
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSY9ab07d6b-ae4a-a310-5572-b266676cd29e8
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSY9ab07d6b-ae4a-a310-5572-b266676cd29e8
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSY9ab07d6b-ae4a-a310-5572-b266676cd29e8
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSY9ab07d6b-ae4a-a310-5572-b266676cd29e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-626-011671406260130 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-626-01) 2017-06-200000-00-00NoNoCurrent