FDA.reportPublic FDA data

Lamotrigine

Product NDC
71335-1919
11-digit product format
713351919
Labeler code
71335
Product ID
71335-1919_cf03f130-067f-401c-8501-0d78a989a319
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
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
71335-1919-1Lamotrigine30 in 1 BOTTLETABLET30104
71335-1919-2Lamotrigine60 in 1 BOTTLETABLET60104
71335-1919-3Lamotrigine90 in 1 BOTTLETABLET90104
71335-1919-4Lamotrigine45 in 1 BOTTLETABLET45104
71335-1919-5Lamotrigine180 in 1 BOTTLETABLET180104
71335-1919-6Lamotrigine14 in 1 BOTTLETABLET14104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1919-3EA - Each71335-1919827c46a6-4ef4-4f2e-a2b7-50962b0cd22c12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1919LAMOTRIGINE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20240509_cf03f130-067f-401c-8501-0d78a989a319.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198429lamoTRIgine 200 MG Oral TabletPSNcf03f130-067f-401c-8501-0d78a989a319104
198429lamotrigine 200 MG Oral TabletSCDcf03f130-067f-401c-8501-0d78a989a319104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1919-17133519190130 TABLET in 1 BOTTLE (71335-1919-1) 30 tablet2021-07-220000-00-00NoNoCurrent
71335-1919-27133519190260 TABLET in 1 BOTTLE (71335-1919-2) 60 tablet2024-07-260000-00-00NoNoCurrent
71335-1919-37133519190390 TABLET in 1 BOTTLE (71335-1919-3) 90 tablet2024-10-150000-00-00NoNoCurrent
71335-1919-47133519190445 TABLET in 1 BOTTLE (71335-1919-4) 45 tablet2025-06-160000-00-00NoNoCurrent
71335-1919-571335191905180 TABLET in 1 BOTTLE (71335-1919-5) 180 tablet2025-06-160000-00-00NoNoCurrent
71335-1919-67133519190614 TABLET in 1 BOTTLE (71335-1919-6) 14 tablet2025-06-160000-00-00NoNoCurrent