Lamotrigine

Product NDC
16714-701
11-digit product format
167140701
Labeler code
16714
Product ID
16714-701_49ac8d1f-a564-4bb1-98cf-7c6d1c7dfdc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078956
Marketing category
ANDA
Marketing start
2009-01-27
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-701-01EA - Each16714-7013656531f-b4c7-4433-8604-bddb9ccc8d9412017-05-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-701-0116714070101100 TABLET in 1 BOTTLE (16714-701-01) 100 tablet2009-01-270000-00-00NoNoCurrent