lacosamide

Generic: lacosamide

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

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lacosamide 200 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-351
Product ID 69367-351_600757f7-b2e8-4c8e-aaf6-c468d7ada9a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205237
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2023-07-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367351
Hyphenated Format 69367-351

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
UPC
0369367351607 0369367350600 0369367348607 0369367349604
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 ANDA205237 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-351-60)
source: ndc

Packages (1)

69367-351-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-351-60)

Ingredients (1)

lacosamide (200 mg/1)

Linked Drug Pages (1)

Lacosamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "600757f7-b2e8-4c8e-aaf6-c468d7ada9a5", "openfda": {"nui": ["N0000008486"], "upc": ["0369367351607", "0369367350600", "0369367348607", "0369367349604"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["ecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb86"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-351-60)", "package_ndc": "69367-351-60", "marketing_start_date": "20230710"}], "brand_name": "Lacosamide", "product_id": "69367-351_600757f7-b2e8-4c8e-aaf6-c468d7ada9a5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69367-351", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "200 mg/1"}], "application_number": "ANDA205237", "marketing_category": "ANDA", "marketing_start_date": "20230710", "listing_expiration_date": "20271231"}