Lacosamide

Product NDC
65162-923
11-digit product format
651620923
Labeler code
65162
Product ID
65162-923_4f62fcbd-17ca-4664-9215-da51ba027b22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204857
Marketing category
ANDA
Marketing start
2022-03-21
Marketing end
0000-00-00
Substance
LACOSAMIDE
Active strength
50 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule
CV
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
65162-923-06EA - Each65162-923e826632d-32e2-4012-b89e-441bf7dfd0e112022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-923LACOSAMIDE TABLET [AMNEAL PHARMACEUTICALS LLC]32Legacy NDC20240215_70782d6e-9dd1-400c-bd3e-511cdb26e24a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-923-066516209230660 TABLET in 1 BOTTLE (65162-923-06) 60 tablet2022-03-210000-00-00NoNoCurrent
65162-923-5065162092350500 TABLET in 1 BOTTLE (65162-923-50) 500 tablet2022-03-210000-00-00NoNoCurrent