lacosamide

Generic: lacosamide

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lacosamide 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7245
Product ID 0904-7245_2ced4e9b-b558-4534-bb96-99da562710a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214695
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047245
Hyphenated Format 0904-7245

Supplemental Identifiers

RxCUI
809987 809992 809996 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
  • 100 mg/1
source: ndc
Packaging
  • 60 BLISTER PACK in 1 CARTON (0904-7245-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7245-68 60 BLISTER PACK in 1 CARTON (0904-7245-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "2ced4e9b-b558-4534-bb96-99da562710a3", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["c83d2156-4dde-4316-98f1-b3dc751f3eac"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "60 BLISTER PACK in 1 CARTON (0904-7245-68)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7245-68", "marketing_start_date": "20220401"}], "brand_name": "Lacosamide", "product_id": "0904-7245_2ced4e9b-b558-4534-bb96-99da562710a3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0904-7245", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA214695", "marketing_category": "ANDA", "marketing_start_date": "20220401", "listing_expiration_date": "20261231"}