Lamotrigine

Product NDC
55700-626
11-digit product format
557000626
Labeler code
55700
Product ID
55700-626_b0956a08-9251-467a-8d5c-711a862eebb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA090170
Marketing category
ANDA
Marketing start
2018-05-18
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-626-305570006263030 TABLET in 1 BOTTLE, PLASTIC (55700-626-30) 30 tablet2018-05-180000-00-00NoNoCurrent
55700-626-605570006266060 TABLET in 1 BOTTLE, PLASTIC (55700-626-60) 60 tablet2018-07-060000-00-00NoNoCurrent