NDC 63850-0053

Lacosamide

Lacosamide

Lacosamide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Natco Pharma Limited. The primary component is Lacosamide.

Product ID63850-0053_f7121f99-b30f-4286-aac0-bc9b59eb0e59
NDC63850-0053
Product TypeHuman Prescription Drug
Proprietary NameLacosamide
Generic NameLacosamide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA204921
Labeler NameNatco Pharma Limited
Substance NameLACOSAMIDE
Active Ingredient Strength50 mg/1
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 63850-0053-1

60 TABLET, FILM COATED in 1 BOTTLE (63850-0053-1)
Marketing Start Date2016-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63850-0053-1 [63850005301]

Lacosamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204921
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-28
Inactivation Date2020-01-31

NDC 63850-0053-2 [63850005302]

Lacosamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204921
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LACOSAMIDE50 mg/1

OpenFDA Data

SPL SET ID:f7121f99-b30f-4286-aac0-bc9b59eb0e59
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 809992
  • 809987
  • 809996
  • 810000
  • UPC Code
  • 0363850005312
  • 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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