lacosamide

Generic: lacosamide

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler somerset therapeutics, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-471
Product ID 70069-471_7d259027-e0df-41af-8ead-40aebffd8b59
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214960
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-10-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069471
Hyphenated Format 70069-471

Supplemental Identifiers

RxCUI
809974
UPC
0370069471104 0370069471012
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 ANDA214960 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (70069-471-10) / 20 mL in 1 VIAL, SINGLE-DOSE (70069-471-01)
source: ndc

Packages (1)

70069-471-10 10 VIAL, SINGLE-DOSE in 1 CARTON (70069-471-10) / 20 mL in 1 VIAL, SINGLE-DOSE (70069-471-01)

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": "7d259027-e0df-41af-8ead-40aebffd8b59", "openfda": {"nui": ["N0000008486"], "upc": ["0370069471104", "0370069471012"], "unii": ["563KS2PQY5"], "rxcui": ["809974"], "spl_set_id": ["00203a7b-e774-45f7-ac6b-48db6d32a48a"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70069-471-10)  / 20 mL in 1 VIAL, SINGLE-DOSE (70069-471-01)", "package_ndc": "70069-471-10", "marketing_start_date": "20241010"}], "brand_name": "LACOSAMIDE", "product_id": "70069-471_7d259027-e0df-41af-8ead-40aebffd8b59", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70069-471", "dea_schedule": "CV", "generic_name": "LACOSAMIDE", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LACOSAMIDE", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA214960", "marketing_category": "ANDA", "marketing_start_date": "20241010", "listing_expiration_date": "20261231"}