Lamotrigine

Product NDC
70518-1523
11-digit product format
705181523
Labeler code
70518
Product ID
70518-1523_e52f8b5a-10a2-79f9-e053-2995a90a256a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078525
Marketing category
ANDA
Marketing start
2018-10-11
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1523LAMOTRIGINE TABLET [REMEDYREPACK INC.]13Legacy NDC20250226_c63b5fca-dc67-414f-a949-6f3e5c730738.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1523-170518152301100 POUCH in 1 BOX (70518-1523-1) > 1 TABLET in 1 POUCH (70518-1523-2) 100 pouch2022-04-060000-00-00NoNoCurrent