Lacosamide

Product NDC
0904-7463
11-digit product format
009047463
Labeler code
0904
Product ID
0904-7463_6e6658af-c86d-4c22-8bd1-3c36e7cece85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA216151
Marketing category
ANDA
Marketing start
2023-04-28
Substance
LACOSAMIDE
Active strength
50 mg/5mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
563KS2PQY5LACOSAMIDE175481-36-4LACOSAMIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7463-68009047463681 TRAY in 1 CASE (0904-7463-68) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7463-41) 1 tray2023-04-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LacosamideMajor Pharmaceuticals2024-07-22HUMAN PRESCRIPTION DRUG LABEL16