LAMICTAL

Product NDC
55289-410
11-digit product format
552890410
Labeler code
55289
Product ID
55289-410_e235bc7d-4d25-240e-e053-2a95a90ad235
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA020241
Marketing category
NDA
Marketing start
1995-01-17
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
55289-410-30EA - Each55289-41065b41262-fe6d-4b5f-a707-74fde4b7da5012012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-410-305528904103030 TABLET in 1 BOTTLE, PLASTIC (55289-410-30) 30 tablet2011-12-190000-00-00NoNoCurrent