Lamotrigine

Product NDC
71335-0706
11-digit product format
713350706
Labeler code
71335
Product ID
71335-0706_e3e6d6b4-2751-474c-94f2-db12af681156
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090170
Marketing category
ANDA
Marketing start
2011-11-01
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U3H27498KSLAMOTRIGINE84057-84-1LAMOTRIGINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-0706-17133507060130 TABLET in 1 BOTTLE (71335-0706-1) 30 tablet2018-02-22NoNoHistorical
71335-0706-27133507060260 TABLET in 1 BOTTLE (71335-0706-2) 60 tablet2018-03-13NoNoHistorical
71335-0706-37133507060390 TABLET in 1 BOTTLE (71335-0706-3) 90 tablet2019-10-08NoNoHistorical
71335-0706-471335070604120 TABLET in 1 BOTTLE (71335-0706-4) 120 tablet2021-12-27NoNoHistorical
71335-0706-57133507060545 TABLET in 1 BOTTLE (71335-0706-5) 45 tablet2021-12-27NoNoHistorical
71335-0706-671335070606180 TABLET in 1 BOTTLE (71335-0706-6) 180 tablet2019-09-26NoNoHistorical
71335-0706-77133507060714 TABLET in 1 BOTTLE (71335-0706-7) 14 tablet2019-10-24NoNoHistorical
71335-0706-871335070608100 TABLET in 1 BOTTLE (71335-0706-8) 100 tablet2020-04-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LamotrigineBryant Ranch Prepack2025-09-17HUMAN PRESCRIPTION DRUG LABEL17