lacosamide

Generic: lacosamide

Labeler: marlex pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lacosamide 100 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 10135-800
Product ID 10135-800_67afbd17-4406-4e18-a302-c0a5829ec903
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218014
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135800
Hyphenated Format 10135-800

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
UPC
0310135800605 0310135799602 0310135802609
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 ANDA218014 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-800-60)
source: ndc

Packages (1)

10135-800-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-800-60)

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": "67afbd17-4406-4e18-a302-c0a5829ec903", "openfda": {"nui": ["N0000008486"], "upc": ["0310135800605", "0310135799602", "0310135802609"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["0a273024-c2d2-4fae-90c3-b2f38a323f24"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-800-60)", "package_ndc": "10135-800-60", "marketing_start_date": "20250701"}], "brand_name": "Lacosamide", "product_id": "10135-800_67afbd17-4406-4e18-a302-c0a5829ec903", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "10135-800", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Marlex Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA218014", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}