lacosamide

Generic: lacosamide

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lacosamide 200 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-367
Product ID 29300-367_d452fee5-4940-4740-8c4d-8024788eafc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213109
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300367
Hyphenated Format 29300-367

Supplemental Identifiers

RxCUI
809987 809992 809996 810000
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 ANDA213109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (29300-367-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (29300-367-16)
source: ndc

Packages (2)

29300-367-05 500 TABLET, FILM COATED in 1 BOTTLE (29300-367-05) 29300-367-16 60 TABLET, FILM COATED in 1 BOTTLE (29300-367-16)

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": "d452fee5-4940-4740-8c4d-8024788eafc6", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809987", "809992", "809996", "810000"], "spl_set_id": ["7ed5cebe-470e-48a4-86ec-2ce79cc32688"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (29300-367-05)", "package_ndc": "29300-367-05", "marketing_start_date": "20241201"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (29300-367-16)", "package_ndc": "29300-367-16", "marketing_start_date": "20241201"}], "brand_name": "Lacosamide", "product_id": "29300-367_d452fee5-4940-4740-8c4d-8024788eafc6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "29300-367", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "200 mg/1"}], "application_number": "ANDA213109", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}