NDC 65162-912

Lacosamide

Lacosamide

Lacosamide is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York, Llc. The primary component is Lacosamide.

Product ID65162-912_32fb4b27-d0ee-4fb9-9f4f-f3845999d299
NDC65162-912
Product TypeHuman Prescription Drug
Proprietary NameLacosamide
Generic NameLacosamide
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2013-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA204839
Labeler NameAmneal Pharmaceuticals of New York, LLC
Substance NameLACOSAMIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA ScheduleCV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 65162-912-68

465 mL in 1 BOTTLE (65162-912-68)
Marketing Start Date2013-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-912-68 [65162091268]

Lacosamide SOLUTION
Marketing CategoryANDA
Application NumberANDA204839
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-11-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LACOSAMIDE10 mg/mL

OpenFDA Data

SPL SET ID:a2c72461-3538-4a38-8994-e5fb1637c294
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993856
  • UPC Code
  • 0365162912685
  • Pharmacological Class

    • Anti-epileptic Agent [EPC]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

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

    NDCBrand NameGeneric Name
    0121-0992LacosamideLacosamide
    0121-1984LacosamideLacosamide
    0121-2976LacosamideLacosamide
    0121-3968LacosamideLacosamide
    63850-0055LacosamideLacosamide
    63850-0053LacosamideLacosamide
    63850-0054LacosamideLacosamide
    63850-0056LacosamideLacosamide
    65162-912LacosamideLacosamide
    0131-1810Vimpatlacosamide
    0131-2470Vimpatlacosamide
    0131-2477Vimpatlacosamide
    0131-2478Vimpatlacosamide
    0131-2479Vimpatlacosamide

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