LAMOTRIGINE

Product NDC
43063-259
11-digit product format
430630259
Labeler code
43063
Product ID
43063-259_db70db85-2e89-893c-e053-2a95a90a4be2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078947
Marketing category
ANDA
Marketing start
2009-01-27
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
150 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
43063-259-304306302593030 TABLET in 1 BOTTLE, PLASTIC (43063-259-30) 30 tablet2009-08-060000-00-00NoNoCurrent
43063-259-604306302596060 TABLET in 1 BOTTLE, PLASTIC (43063-259-60) 60 tablet2009-08-060000-00-00NoNoCurrent