Lamotrigine

Product NDC
70518-2716
11-digit product format
705182716
Labeler code
70518
Product ID
70518-2716_ec6ca7ef-ff7d-6200-e053-2995a90ae12a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078525
Marketing category
ANDA
Marketing start
2020-04-30
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
200 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
70518-2716-07051827160030 POUCH in 1 BOX (70518-2716-0) > 1 TABLET in 1 POUCH (70518-2716-1) 30 pouch2020-04-300000-00-00NoNoCurrent