FDA.reportPublic FDA data

Lamotrigine

Product NDC
60687-704
11-digit product format
606870704
Labeler code
60687
Product ID
60687-704_4c0eeb34-9d52-f6e8-e063-6294a90a4eff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077633
Marketing category
ANDA
Marketing start
2023-01-17
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
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
LAMOTRIGINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui198428, 198429

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
60687-704-01Lamotrigine100 in 1 CARTONTABLET1003
60687-704-11Lamotrigine1 in 1 BLISTER PACKTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-704-01EA - Each60687-70487f77563-17e7-422b-9d05-487dac2a129712023-01-09
60687-704-11EA - Each60687-704477feaae-763b-4df5-be96-2c120d3ae4f712023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-704LAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]2Current NDC, Legacy NDC, 2 package rows20240807_6034a8b8-9e80-43ca-b84f-ea82f788268c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198428lamoTRIgine 150 MG Oral TabletPSN6034a8b8-9e80-43ca-b84f-ea82f788268c3
198429lamoTRIgine 200 MG Oral TabletPSN6034a8b8-9e80-43ca-b84f-ea82f788268c3
198428lamotrigine 150 MG Oral TabletSCD6034a8b8-9e80-43ca-b84f-ea82f788268c3
198429lamotrigine 200 MG Oral TabletSCD6034a8b8-9e80-43ca-b84f-ea82f788268c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-704-0160687070401100 BLISTER PACK in 1 CARTON (60687-704-01) / 1 TABLET in 1 BLISTER PACK (60687-704-11) 100 blister pack2023-01-170000-00-00NoNoCurrent
60687-704-11606870704111 in 1 BLISTER PACKHistorical