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 SOLUTION
Routes
ORAL
Active Ingredients

lacosamide 50 mg/5mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7463
Product ID 0904-7463_6e6658af-c86d-4c22-8bd1-3c36e7cece85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216151
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-04-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047463
Hyphenated Format 0904-7463

Supplemental Identifiers

RxCUI
993856
UPC
0309047464661 0309047463411
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 ANDA216151 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 1 TRAY in 1 CASE (0904-7463-68) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7463-41)
source: ndc

Packages (1)

0904-7463-68 1 TRAY in 1 CASE (0904-7463-68) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7463-41)

Ingredients (1)

lacosamide (50 mg/5mL)

Linked Drug Pages (1)

Lacosamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6e6658af-c86d-4c22-8bd1-3c36e7cece85", "openfda": {"nui": ["N0000008486"], "upc": ["0309047464661", "0309047463411"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["973cea8d-e516-4014-a116-c5990554a550"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CASE (0904-7463-68)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7463-41)", "package_ndc": "0904-7463-68", "marketing_start_date": "20230428"}], "brand_name": "Lacosamide", "product_id": "0904-7463_6e6658af-c86d-4c22-8bd1-3c36e7cece85", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0904-7463", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "50 mg/5mL"}], "application_number": "ANDA216151", "marketing_category": "ANDA", "marketing_start_date": "20230428", "listing_expiration_date": "20261231"}