lacosamide

Generic: lacosamide

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-204
Product ID 65219-204_0f09367f-3191-41f4-891c-abdd7ed3cecd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214677
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219204
Hyphenated Format 65219-204

Supplemental Identifiers

RxCUI
809974
UPC
0365219204015
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 ANDA214677 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-204-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-204-01)
source: ndc

Packages (1)

65219-204-20 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-204-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-204-01)

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": "0f09367f-3191-41f4-891c-abdd7ed3cecd", "openfda": {"nui": ["N0000008486"], "upc": ["0365219204015"], "unii": ["563KS2PQY5"], "rxcui": ["809974"], "spl_set_id": ["419ff519-2b19-4fb9-adfa-868ba0229407"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (65219-204-20)  / 20 mL in 1 VIAL, SINGLE-DOSE (65219-204-01)", "package_ndc": "65219-204-20", "marketing_start_date": "20220725"}], "brand_name": "Lacosamide", "product_id": "65219-204_0f09367f-3191-41f4-891c-abdd7ed3cecd", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65219-204", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA214677", "marketing_category": "ANDA", "marketing_start_date": "20220725", "listing_expiration_date": "20261231"}