LAMOTRIGINE

Product NDC
50090-6028
11-digit product format
500906028
Labeler code
50090
Product ID
50090-6028_ffcfa748-953b-4d6f-aea9-bff55e7a2bac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078947
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U3H27498KSLAMOTRIGINE84057-84-1LAMOTRIGINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6028-05009060280060 TABLET in 1 BOTTLE (50090-6028-0) 60 tablet2022-07-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LAMOTRIGINEA-S Medication Solutions2023-04-30HUMAN PRESCRIPTION DRUG LABEL7