lacosamide

Generic: lacosamide

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

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler aurobindo pharma limited
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-016
Product ID 59651-016_d876faa2-0bdd-4016-9950-8421327803f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209224
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-01-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651016
Hyphenated Format 59651-016

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 (59651-016-02)
  • 465 mL in 1 BOTTLE, PLASTIC (59651-016-46)
source: ndc

Packages (2)

59651-016-02 200 mL in 1 BOTTLE, PLASTIC (59651-016-02) 59651-016-46 465 mL in 1 BOTTLE, PLASTIC (59651-016-46)

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": "d876faa2-0bdd-4016-9950-8421327803f7", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["614490ce-a62c-4222-8e4b-ce802cf63028"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 mL in 1 BOTTLE, PLASTIC (59651-016-02)", "package_ndc": "59651-016-02", "marketing_start_date": "20240124"}, {"sample": false, "description": "465 mL in 1 BOTTLE, PLASTIC (59651-016-46)", "package_ndc": "59651-016-46", "marketing_start_date": "20240124"}], "brand_name": "Lacosamide", "product_id": "59651-016_d876faa2-0bdd-4016-9950-8421327803f7", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "59651-016", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Aurobindo Pharma Limited", "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": "20240124", "listing_expiration_date": "20261231"}