Lacosamide Oral Solution

Product NDC
62135-885
11-digit product format
621350885
Labeler code
62135
Product ID
62135-885_2df7ee04-2970-8b37-e063-6294a90a29a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA215154
Marketing category
ANDA
Marketing start
2024-05-15
Substance
LACOSAMIDE
Active strength
10 mg/mL
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
62135-885-2262135088522200 mL in 1 BOTTLE (62135-885-22) 200 ml2024-11-27NoNoHistorical
62135-885-23621350885232 TRAY in 1 BOX (62135-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-885-10) 2 tray2025-02-10NoNoHistorical
62135-885-24621350885242 TRAY in 1 BOX (62135-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-885-05) 2 tray2025-02-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Lacosamide Oral SolutionChartwell RX, LLC2025-02-12HUMAN PRESCRIPTION DRUG LABEL2