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 ID: 63850-0053_f7121f99-b30f-4286-aac0-bc9b59eb0e59
• NDC: 63850-0053
• Product Type: Human Prescription Drug
• Proprietary Name: Lacosamide
• Generic Name: Lacosamide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204921
• Labeler Name: Natco Pharma Limited
• Substance Name: LACOSAMIDE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
• DEA Schedule: CV
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 63850-0053-1

60 TABLET, FILM COATED in 1 BOTTLE (63850-0053-1)

• Marketing Start Date: 2016-05-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63850-0053-1 [63850005301]

Lacosamide TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA204921
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-28
• Inactivation Date: 2020-01-31

NDC 63850-0053-2 [63850005302]

Lacosamide TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA204921
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
LACOSAMIDE	50 mg/1

OpenFDA Data

• SPL SET ID: f7121f99-b30f-4286-aac0-bc9b59eb0e59
• Manufacturer:
  • Natco Pharma Limited
• UNII:
  • 563KS2PQY5
• 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"

NDC	Brand Name	Generic Name
0121-0992	Lacosamide	Lacosamide
0121-1984	Lacosamide	Lacosamide
0121-2976	Lacosamide	Lacosamide
0121-3968	Lacosamide	Lacosamide
63850-0055	Lacosamide	Lacosamide
63850-0053	Lacosamide	Lacosamide
63850-0054	Lacosamide	Lacosamide
63850-0056	Lacosamide	Lacosamide
65162-912	Lacosamide	Lacosamide
0131-1810	Vimpat	lacosamide
0131-2470	Vimpat	lacosamide
0131-2477	Vimpat	lacosamide
0131-2478	Vimpat	lacosamide
0131-2479	Vimpat	lacosamide