lacosamide

Generic: lacosamide

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lacosamide 50 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0510
Product ID 80425-0510_325df1f8-167c-c07c-e063-6294a90a96fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214695
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2025-04-09

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250510
Hyphenated Format 80425-0510

Supplemental Identifiers

RxCUI
810000
UNII
563KS2PQY5
NUI
N0000008486

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lacosamide (source: ndc)
Generic Name lacosamide (source: ndc)
Application Number ANDA214695 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0510-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0510-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0510-3)
source: ndc

Packages (3)

80425-0510-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0510-1) 80425-0510-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0510-2) 80425-0510-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0510-3)

Ingredients (1)

lacosamide (50 mg/1)

Linked Drug Pages (1)

Lacosamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "325df1f8-167c-c07c-e063-6294a90a96fb", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["810000"], "spl_set_id": ["325df1b7-4908-0c03-e063-6294a90ad844"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0510-1)", "package_ndc": "80425-0510-1", "marketing_start_date": "20250409"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0510-2)", "package_ndc": "80425-0510-2", "marketing_start_date": "20250409"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0510-3)", "package_ndc": "80425-0510-3", "marketing_start_date": "20250409"}], "brand_name": "Lacosamide", "product_id": "80425-0510_325df1f8-167c-c07c-e063-6294a90a96fb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "80425-0510", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA214695", "marketing_category": "ANDA", "marketing_start_date": "20250409", "listing_expiration_date": "20261231"}