lacosamide

Generic: lacosamide

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler northstar rx llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-305
Product ID 72603-305_e70388c9-39ef-4803-8a10-d46902a45462
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209224
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603305
Hyphenated Format 72603-305

Supplemental Identifiers

RxCUI
993856
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 ANDA209224 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 200 mL in 1 BOTTLE, PLASTIC (72603-305-01)
source: ndc

Packages (1)

72603-305-01 200 mL in 1 BOTTLE, PLASTIC (72603-305-01)

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": ["ORAL"], "spl_id": "e70388c9-39ef-4803-8a10-d46902a45462", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["48fcaa27-baaa-446e-a282-0c3e232cd151"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 mL in 1 BOTTLE, PLASTIC (72603-305-01)", "package_ndc": "72603-305-01", "marketing_start_date": "20240601"}], "brand_name": "Lacosamide", "product_id": "72603-305_e70388c9-39ef-4803-8a10-d46902a45462", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72603-305", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA209224", "marketing_category": "ANDA", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}