lacosamide

Generic: lacosamide

Labeler: virtus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler virtus pharmaceuticals, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Virtus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69543-455
Product ID 69543-455_21cd2911-f9de-4d64-b2b3-409a8eb01b8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215628
DEA Schedule cv
Marketing Start 2023-04-17
Marketing End 2027-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69543455
Hyphenated Format 69543-455

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, GLASS in 1 CARTON (69543-455-10) / 20 mL in 1 VIAL, GLASS (69543-455-20)
source: ndc

Packages (1)

69543-455-10 10 VIAL, GLASS in 1 CARTON (69543-455-10) / 20 mL in 1 VIAL, GLASS (69543-455-20)

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": "21cd2911-f9de-4d64-b2b3-409a8eb01b8d", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809974"], "spl_set_id": ["01162e2f-967b-4596-8188-c0d9889c3814"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Virtus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (69543-455-10)  / 20 mL in 1 VIAL, GLASS (69543-455-20)", "package_ndc": "69543-455-10", "marketing_end_date": "20270930", "marketing_start_date": "20230417"}], "brand_name": "LACOSAMIDE", "product_id": "69543-455_21cd2911-f9de-4d64-b2b3-409a8eb01b8d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69543-455", "dea_schedule": "CV", "generic_name": "LACOSAMIDE", "labeler_name": "Virtus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LACOSAMIDE", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA215628", "marketing_category": "ANDA", "marketing_end_date": "20270930", "marketing_start_date": "20230417"}