FDA.reportPublic FDA data

Lamotrigine

Product NDC
82804-068
11-digit product format
828040068
Labeler code
82804
Product ID
82804-068_6f7e59d2-4311-42a0-93a0-b29b0417d96f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090170
Marketing category
ANDA
Marketing start
2011-11-01
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
Rxcui198429

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
82804-068-30Lamotrigine30 in 1 BOTTLE, PLASTICTABLET301
82804-068-60Lamotrigine60 in 1 BOTTLE, PLASTICTABLET601
82804-068-90Lamotrigine90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-068-30EA - Each82804-068954c1fd5-2cba-450b-affa-6ed2d1b1ba8612024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-068LAMOTRIGINE TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20240208_6f7e59d2-4311-42a0-93a0-b29b0417d96f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198429lamoTRIgine 200 MG Oral TabletPSN6f7e59d2-4311-42a0-93a0-b29b0417d96f1
198429lamotrigine 200 MG Oral TabletSCD6f7e59d2-4311-42a0-93a0-b29b0417d96f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-068-308280400683030 TABLET in 1 BOTTLE, PLASTIC (82804-068-30) 30 tablet2024-01-31NoNoCurrent
82804-068-608280400686060 TABLET in 1 BOTTLE, PLASTIC (82804-068-60) 60 tablet2024-01-31NoNoCurrent
82804-068-908280400689090 TABLET in 1 BOTTLE, PLASTIC (82804-068-90) 90 tablet2024-01-31NoNoCurrent