NDC 68083-480

Lacosamide

Lacosamide

Lacosamide is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Lacosamide.

Product ID68083-480_fa3e7557-80ab-4881-a1f3-1a96a0f4ab5c
NDC68083-480
Product TypeHuman Prescription Drug
Proprietary NameLacosamide
Generic NameLacosamide
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-09-19
Marketing CategoryANDA /
Application NumberANDA215628
Labeler NameGland Pharma Limited
Substance NameLACOSAMIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68083-480-10

10 VIAL, SINGLE-DOSE in 1 CARTON (68083-480-10) > 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2022-09-19
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Lacosamide" or generic name "Lacosamide"

NDCBrand NameGeneric Name
63850-0055LacosamideLacosamide
63850-0053LacosamideLacosamide
63850-0054LacosamideLacosamide
63850-0056LacosamideLacosamide
65162-912LacosamideLacosamide
0131-1810Vimpatlacosamide
0131-2470Vimpatlacosamide
0131-2477Vimpatlacosamide
0131-2478Vimpatlacosamide
0131-2479Vimpatlacosamide
0131-2480Vimpatlacosamide

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