lacosamide

Generic: lacosamide

Labeler: glenmark pharmaceuticals inc. usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler glenmark pharmaceuticals inc. usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lacosamide 200 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc. USA

Identifiers & Regulatory

Product NDC 68462-681
Product ID 68462-681_a496c733-ce38-4566-83f9-0287506f4506
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205006
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-03-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462681
Hyphenated Format 68462-681

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
UPC
0368462681602 0368462679609 0368462678602 0368462680605
UNII
563KS2PQY5
NUI
N0000008486

Packaging Origin

Original Packager
true

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 ANDA205006 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68462-681-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68462-681-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68462-681-60)
source: ndc

Packages (3)

68462-681-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-681-10) 68462-681-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-681-30) 68462-681-60 60 TABLET, FILM COATED in 1 BOTTLE (68462-681-60)

Ingredients (1)

lacosamide (200 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": "a496c733-ce38-4566-83f9-0287506f4506", "openfda": {"nui": ["N0000008486"], "upc": ["0368462681602", "0368462679609", "0368462678602", "0368462680605"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["df1d2e6a-6129-49c9-b2c1-0fdf73f38b9c"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc. USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-681-10)", "package_ndc": "68462-681-10", "marketing_start_date": "20220318"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68462-681-30)", "package_ndc": "68462-681-30", "marketing_start_date": "20220318"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68462-681-60)", "package_ndc": "68462-681-60", "marketing_start_date": "20220318"}], "brand_name": "lacosamide", "product_id": "68462-681_a496c733-ce38-4566-83f9-0287506f4506", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68462-681", "dea_schedule": "CV", "generic_name": "lacosamide", "labeler_name": "Glenmark Pharmaceuticals Inc. USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "200 mg/1"}], "application_number": "ANDA205006", "marketing_category": "ANDA", "marketing_start_date": "20220318", "listing_expiration_date": "20261231"}