lacosamide

Generic: lacosamide

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler apotex corp
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-6235
Product ID 60505-6235_ac0cc20b-2d3d-443f-c447-71aef269849e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216670
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-02-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056235
Hyphenated Format 60505-6235

Supplemental Identifiers

RxCUI
809974
UPC
0360505623549
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 ANDA216670 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6235-4) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

60505-6235-4 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6235-4) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

lacosamide (10 mg/mL)

Linked Drug Pages (1)

Lacosamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ac0cc20b-2d3d-443f-c447-71aef269849e", "openfda": {"nui": ["N0000008486"], "upc": ["0360505623549"], "unii": ["563KS2PQY5"], "rxcui": ["809974"], "spl_set_id": ["2c53d6c3-fe18-dce6-a710-cb874fbf0c59"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6235-4)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "60505-6235-4", "marketing_start_date": "20240220"}], "brand_name": "Lacosamide", "product_id": "60505-6235_ac0cc20b-2d3d-443f-c447-71aef269849e", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "60505-6235", "dea_schedule": "CV", "generic_name": "lacosamide", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA216670", "marketing_category": "ANDA", "marketing_start_date": "20240220", "listing_expiration_date": "20261231"}