lacosamide

Generic: lacosamide

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lacosamide 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-991
Product ID 82804-991_47ae2f1f-d135-4f4e-acc2-500c1afa7b8b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205237
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-07-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804991
Hyphenated Format 82804-991

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
UPC
0382804993307 0382804991303 0382804990306 0382804992300
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 ANDA205237 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-00)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-11)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-30)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-55)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-60)
  • 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-64)
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-72)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-78)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-90)
source: ndc

Packages (9)

82804-991-00 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-00) 82804-991-11 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-11) 82804-991-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-30) 82804-991-55 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-55) 82804-991-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-60) 82804-991-64 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-64) 82804-991-72 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-72) 82804-991-78 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-78) 82804-991-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-90)

Ingredients (1)

lacosamide (100 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": "47ae2f1f-d135-4f4e-acc2-500c1afa7b8b", "openfda": {"nui": ["N0000008486"], "upc": ["0382804993307", "0382804991303", "0382804990306", "0382804992300"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["47ae2f1f-d135-4f4e-acc2-500c1afa7b8b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-00)", "package_ndc": "82804-991-00", "marketing_start_date": "20240521"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-11)", "package_ndc": "82804-991-11", "marketing_start_date": "20240521"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-30)", "package_ndc": "82804-991-30", "marketing_start_date": "20240521"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-55)", "package_ndc": "82804-991-55", "marketing_start_date": "20240521"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-60)", "package_ndc": "82804-991-60", "marketing_start_date": "20240521"}, {"sample": false, "description": "240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-64)", "package_ndc": "82804-991-64", "marketing_start_date": "20240521"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-72)", "package_ndc": "82804-991-72", "marketing_start_date": "20240521"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-78)", "package_ndc": "82804-991-78", "marketing_start_date": "20240521"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-90)", "package_ndc": "82804-991-90", "marketing_start_date": "20240521"}], "brand_name": "Lacosamide", "product_id": "82804-991_47ae2f1f-d135-4f4e-acc2-500c1afa7b8b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "82804-991", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA205237", "marketing_category": "ANDA", "marketing_start_date": "20230710", "listing_expiration_date": "20261231"}