LAMOTRIGINE

Product NDC
72189-063
11-digit product format
721890063
Labeler code
72189
Product ID
72189-063_2c4eb5ab-60c5-a669-e063-6394a90a27fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090170
Marketing category
ANDA
Marketing start
2020-06-16
Substance
LAMOTRIGINE
Active strength
25 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
72189-063-307218900633030 TABLET in 1 BOTTLE (72189-063-30) 30 tablet2020-06-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LAMOTRIGINEDIRECT RX2025-01-22HUMAN PRESCRIPTION DRUG LABEL2