lacosamide

Generic: lacosamide

Labeler: xlcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler xlcare pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
XLCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72865-235
Product ID 72865-235_f3394cab-e834-326c-e053-2a95a90af10e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216335
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-01-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72865235
Hyphenated Format 72865-235

Supplemental Identifiers

RxCUI
809974
UPC
0372865235102 0372865235010
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 ANDA216335 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (72865-235-10) / 20 mL in 1 VIAL, GLASS (72865-235-01)
source: ndc

Packages (1)

72865-235-10 10 VIAL, GLASS in 1 CARTON (72865-235-10) / 20 mL in 1 VIAL, GLASS (72865-235-01)

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": "f3394cab-e834-326c-e053-2a95a90af10e", "openfda": {"nui": ["N0000008486"], "upc": ["0372865235102", "0372865235010"], "unii": ["563KS2PQY5"], "rxcui": ["809974"], "spl_set_id": ["c7793da3-787b-4364-9192-7caab49066f1"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["XLCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (72865-235-10)  / 20 mL in 1 VIAL, GLASS (72865-235-01)", "package_ndc": "72865-235-10", "marketing_start_date": "20230125"}], "brand_name": "LACOSAMIDE", "product_id": "72865-235_f3394cab-e834-326c-e053-2a95a90af10e", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72865-235", "dea_schedule": "CV", "generic_name": "LACOSAMIDE", "labeler_name": "XLCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LACOSAMIDE", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA216335", "marketing_category": "ANDA", "marketing_start_date": "20230125", "listing_expiration_date": "20261231"}