FDA.reportPublic FDA data

Lamotrigine

Product NDC
68788-7871
11-digit product format
687887871
Labeler code
68788
Product ID
68788-7871_2a1f59e0-2c69-4fa9-ab8a-1f7a2163aad7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077633
Marketing category
ANDA
Marketing start
2021-02-15
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
Rxcui198427

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
68788-7871-3Lamotrigine30 in 1 BOTTLETABLET306
68788-7871-6Lamotrigine60 in 1 BOTTLETABLET606
68788-7871-9Lamotrigine90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7871-3EA - Each68788-78718ef4f1d9-8fc5-40d4-b1a6-63aaa2dd55b712021-03-02
68788-7871-6EA - Each68788-787190da6719-8cd5-4be8-b6ef-f9ff791a1a1512021-03-02
68788-7871-9EA - Each68788-7871905ec466-eb1e-46d7-a228-50840597521812021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7871LAMOTRIGINE TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20240607_634dbe6c-4874-4d54-aa25-be02d3341f16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN634dbe6c-4874-4d54-aa25-be02d3341f166
198427lamotrigine 100 MG Oral TabletSCD634dbe6c-4874-4d54-aa25-be02d3341f166

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7871-36878878710330 TABLET in 1 BOTTLE (68788-7871-3) 30 tablet2021-02-150000-00-00NoNoCurrent
68788-7871-66878878710660 TABLET in 1 BOTTLE (68788-7871-6) 60 tablet2021-02-150000-00-00NoNoCurrent
68788-7871-96878878710990 TABLET in 1 BOTTLE (68788-7871-9) 90 tablet2021-02-150000-00-00NoNoCurrent