lacosamide

Generic: lacosamide

Labeler: anthea pharma private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler anthea pharma private limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Anthea Pharma Private Limited

Identifiers & Regulatory

Product NDC 83854-002
Product ID 83854-002_491d8945-109a-8c82-e063-6394a90a7a04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA220268
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2026-01-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83854002
Hyphenated Format 83854-002

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 ANDA220268 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (83854-002-10) / 20 mL in 1 VIAL (83854-002-01)
source: ndc

Packages (1)

83854-002-10 10 VIAL in 1 CARTON (83854-002-10) / 20 mL in 1 VIAL (83854-002-01)

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": "491d8945-109a-8c82-e063-6394a90a7a04", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809974"], "spl_set_id": ["b4f2620a-2047-4b33-bb75-18702f6c55e6"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Anthea Pharma Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (83854-002-10)  / 20 mL in 1 VIAL (83854-002-01)", "package_ndc": "83854-002-10", "marketing_start_date": "20260121"}], "brand_name": "LACOSAMIDE", "product_id": "83854-002_491d8945-109a-8c82-e063-6394a90a7a04", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "83854-002", "dea_schedule": "CV", "generic_name": "LACOSAMIDE", "labeler_name": "Anthea Pharma Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LACOSAMIDE", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA220268", "marketing_category": "ANDA", "marketing_start_date": "20260121", "listing_expiration_date": "20271231"}