lacosamide

Generic: lacosamide

Labeler: tris pharma inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler tris pharma inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lacosamide 100 mg/1

Manufacturer
Tris Pharma Inc

Identifiers & Regulatory

Product NDC 27808-244
Product ID 27808-244_299cd2a3-f5a6-4e6e-8f26-84da23cff30c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208308
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-03-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27808244
Hyphenated Format 27808-244

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
UPC
0327808244017 0327808243010 0327808246011 0327808245014
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 ANDA208308 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (27808-244-01)
source: ndc

Packages (1)

27808-244-01 60 TABLET in 1 BOTTLE (27808-244-01)

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": "299cd2a3-f5a6-4e6e-8f26-84da23cff30c", "openfda": {"nui": ["N0000008486"], "upc": ["0327808244017", "0327808243010", "0327808246011", "0327808245014"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["7f37f8b8-07d3-48c4-a0c4-7652b62a1ad9"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Tris Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (27808-244-01)", "package_ndc": "27808-244-01", "marketing_start_date": "20220319"}], "brand_name": "Lacosamide", "product_id": "27808-244_299cd2a3-f5a6-4e6e-8f26-84da23cff30c", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "27808-244", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Tris Pharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA208308", "marketing_category": "ANDA", "marketing_start_date": "20220319", "listing_expiration_date": "20261231"}