lacosamide

Generic: lacosamide

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-480
Product ID 68083-480_784837da-eb6c-43e1-87ea-367e2d07cd1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215628
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-09-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083480
Hyphenated Format 68083-480

Supplemental Identifiers

RxCUI
809974
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 ANDA215628 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-480-10) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-480-10 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-480-10) / 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": "784837da-eb6c-43e1-87ea-367e2d07cd1c", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809974"], "spl_set_id": ["779d2381-f590-45f9-a191-f44af821f4c8"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (68083-480-10)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-480-10", "marketing_start_date": "20220919"}], "brand_name": "Lacosamide", "product_id": "68083-480_784837da-eb6c-43e1-87ea-367e2d07cd1c", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68083-480", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA215628", "marketing_category": "ANDA", "marketing_start_date": "20220919", "listing_expiration_date": "20261231"}