lacosamide

Generic: lacosamide

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler leading pharma, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-318
Product ID 69315-318_0267a67e-d492-480b-a688-e2cec27142a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216461
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-02-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315318
Hyphenated Format 69315-318

Supplemental Identifiers

RxCUI
993856
UPC
0369315318461
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 ANDA216461 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 200 mL in 1 BOTTLE, PLASTIC (69315-318-20)
  • 465 mL in 1 BOTTLE, PLASTIC (69315-318-46)
source: ndc

Packages (2)

69315-318-20 200 mL in 1 BOTTLE, PLASTIC (69315-318-20) 69315-318-46 465 mL in 1 BOTTLE, PLASTIC (69315-318-46)

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": "0267a67e-d492-480b-a688-e2cec27142a6", "openfda": {"nui": ["N0000008486"], "upc": ["0369315318461"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["45786c84-51ef-4440-bc88-2501951e4c41"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 mL in 1 BOTTLE, PLASTIC (69315-318-20)", "package_ndc": "69315-318-20", "marketing_start_date": "20230725"}, {"sample": false, "description": "465 mL in 1 BOTTLE, PLASTIC (69315-318-46)", "package_ndc": "69315-318-46", "marketing_start_date": "20230725"}], "brand_name": "Lacosamide", "product_id": "69315-318_0267a67e-d492-480b-a688-e2cec27142a6", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69315-318", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA216461", "marketing_category": "ANDA", "marketing_start_date": "20230206", "listing_expiration_date": "20261231"}