FDA.reportPublic FDA data

Lamotrigine

Product NDC
71335-2328
11-digit product format
713352328
Labeler code
71335
Product ID
71335-2328_4bbc140c-6092-416d-865d-49b89c5ecdd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077633
Marketing category
ANDA
Marketing start
2009-01-27
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
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
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
71335-2328-1Lamotrigine30 in 1 BOTTLETABLET30101
71335-2328-2Lamotrigine60 in 1 BOTTLETABLET60101
71335-2328-3Lamotrigine90 in 1 BOTTLETABLET90101
71335-2328-4Lamotrigine120 in 1 BOTTLETABLET120101
71335-2328-5Lamotrigine45 in 1 BOTTLETABLET45101
71335-2328-6Lamotrigine180 in 1 BOTTLETABLET180101
71335-2328-7Lamotrigine14 in 1 BOTTLETABLET14101
71335-2328-8Lamotrigine100 in 1 BOTTLETABLET100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2328-1EA - Each71335-23289df7bb4b-b1f6-4aeb-8a16-c73edaae2cb812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2328LAMOTRIGINE TABLET [BRYANT RANCH PREPACK]100Current NDC, 8 package rows20240119_4bbc140c-6092-416d-865d-49b89c5ecdd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN4bbc140c-6092-416d-865d-49b89c5ecdd0101
198427lamotrigine 100 MG Oral TabletSCD4bbc140c-6092-416d-865d-49b89c5ecdd0101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2328-17133523280130 TABLET in 1 BOTTLE (71335-2328-1) 30 tablet2024-01-09NoNoHistorical
71335-2328-27133523280260 TABLET in 1 BOTTLE (71335-2328-2) 60 tablet2025-06-16NoNoHistorical
71335-2328-37133523280390 TABLET in 1 BOTTLE (71335-2328-3) 90 tablet2024-01-02NoNoHistorical
71335-2328-471335232804120 TABLET in 1 BOTTLE (71335-2328-4) 120 tablet2025-06-16NoNoHistorical
71335-2328-57133523280545 TABLET in 1 BOTTLE (71335-2328-5) 45 tablet2025-06-16NoNoHistorical
71335-2328-671335232806180 TABLET in 1 BOTTLE (71335-2328-6) 180 tablet2025-06-16NoNoHistorical
71335-2328-77133523280714 TABLET in 1 BOTTLE (71335-2328-7) 14 tablet2025-06-16NoNoHistorical
71335-2328-871335232808100 TABLET in 1 BOTTLE (71335-2328-8) 100 tablet2024-05-09NoNoHistorical