lacosamide

Generic: lacosamide

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

Drug Facts

Product Profile

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

lacosamide 200 mg/1

Manufacturer
ScieGen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 50228-195
Product ID 50228-195_56788345-3f8e-478c-b73d-216b4d711b57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205237
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 50228195
Hyphenated Format 50228-195

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
UPC
0350228195607 0350228193603 0350228194600 0350228192606
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 ANDA205237 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50228-195-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-195-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (50228-195-60)
source: ndc

Packages (3)

50228-195-10 1000 TABLET, FILM COATED in 1 BOTTLE (50228-195-10) 50228-195-30 30 TABLET, FILM COATED in 1 BOTTLE (50228-195-30) 50228-195-60 60 TABLET, FILM COATED in 1 BOTTLE (50228-195-60)

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": "56788345-3f8e-478c-b73d-216b4d711b57", "openfda": {"nui": ["N0000008486"], "upc": ["0350228195607", "0350228193603", "0350228194600", "0350228192606"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["f4ffa3ad-1278-4772-9ef8-ed6fdaa47605"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["ScieGen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-195-10)", "package_ndc": "50228-195-10", "marketing_start_date": "20220318"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-195-30)", "package_ndc": "50228-195-30", "marketing_start_date": "20220318"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50228-195-60)", "package_ndc": "50228-195-60", "marketing_start_date": "20220318"}], "brand_name": "LACOSAMIDE", "product_id": "50228-195_56788345-3f8e-478c-b73d-216b4d711b57", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50228-195", "dea_schedule": "CV", "generic_name": "LACOSAMIDE", "labeler_name": "ScieGen Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LACOSAMIDE", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "200 mg/1"}], "application_number": "ANDA205237", "marketing_category": "ANDA", "marketing_start_date": "20220318", "listing_expiration_date": "20261231"}