Lamotrigine

Product NDC
50090-5827
11-digit product format
500905827
Labeler code
50090
Product ID
50090-5827_6fb36b25-a74d-4b04-98a6-c59b9a7fa469
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077633
Marketing category
ANDA
Marketing start
2009-01-27
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5827LAMOTRIGINE TABLET [A-S MEDICATION SOLUTIONS]14Legacy NDC20231125_a4d89cd9-c5d8-490f-996d-fc15b47c7b21.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5827-05009058270030 TABLET in 1 BOTTLE (50090-5827-0) 30 tablet2021-10-260000-00-00NoNoCurrent
50090-5827-15009058270160 TABLET in 1 BOTTLE (50090-5827-1) 60 tablet2021-10-260000-00-00NoNoCurrent
50090-5827-25009058270290 TABLET in 1 BOTTLE (50090-5827-2) 90 tablet2021-10-260000-00-00NoNoCurrent