lacosamide

Generic: lacosamide

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lacosamide 100 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-303
Product ID 33342-303_035d85e5-8688-4390-bd55-74baa91c0e9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208466
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-05-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342303
Hyphenated Format 33342-303

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
UPC
0333342303097 0333342302090
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 ANDA208466 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (33342-303-09)
  • 100 TABLET, FILM COATED in 1 BOTTLE (33342-303-11)
source: ndc

Packages (2)

33342-303-09 60 TABLET, FILM COATED in 1 BOTTLE (33342-303-09) 33342-303-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-303-11)

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": "035d85e5-8688-4390-bd55-74baa91c0e9d", "openfda": {"nui": ["N0000008486"], "upc": ["0333342303097", "0333342302090"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["035d85e5-8688-4390-bd55-74baa91c0e9d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (33342-303-09)", "package_ndc": "33342-303-09", "marketing_start_date": "20240524"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (33342-303-11)", "package_ndc": "33342-303-11", "marketing_start_date": "20240524"}], "brand_name": "Lacosamide", "product_id": "33342-303_035d85e5-8688-4390-bd55-74baa91c0e9d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "33342-303", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA208466", "marketing_category": "ANDA", "marketing_start_date": "20240524", "listing_expiration_date": "20261231"}