LAMOTRIGINE

Product NDC
68071-3607
11-digit product format
680713607
Labeler code
68071
Product ID
68071-3607_1bbbeda6-9835-6c1c-e063-6294a90ad1ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078947
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U3H27498KSLAMOTRIGINE84057-84-1LAMOTRIGINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3607-66807136070660 TABLET in 1 BOTTLE (68071-3607-6) 60 tablet2024-06-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LAMOTRIGINENuCare Pharmaceuticals,Inc.2024-06-25HUMAN PRESCRIPTION DRUG LABEL1