lacosamide

Generic: lacosamide

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler breckenridge pharmaceutical, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lacosamide 100 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-349
Product ID 51991-349_d59d1657-c847-475f-998d-49d186f6697e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204921
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 51991349
Hyphenated Format 51991-349

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
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 ANDA204921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (51991-349-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (51991-349-06)
source: ndc

Packages (2)

51991-349-05 500 TABLET, FILM COATED in 1 BOTTLE (51991-349-05) 51991-349-06 60 TABLET, FILM COATED in 1 BOTTLE (51991-349-06)

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": "d59d1657-c847-475f-998d-49d186f6697e", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["f7ea3ce6-4ca7-4405-a011-48e7d71360a5"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (51991-349-05)", "package_ndc": "51991-349-05", "marketing_start_date": "20220318"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (51991-349-06)", "package_ndc": "51991-349-06", "marketing_start_date": "20220318"}], "brand_name": "LACOSAMIDE", "product_id": "51991-349_d59d1657-c847-475f-998d-49d186f6697e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "51991-349", "dea_schedule": "CV", "generic_name": "LACOSAMIDE", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LACOSAMIDE", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA204921", "marketing_category": "ANDA", "marketing_start_date": "20220318", "listing_expiration_date": "20261231"}