lacosamide

Generic: lacosamide

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lacosamide 200 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4504
Product ID 70518-4504_49ebe440-0aef-da54-e063-6294a90a41cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204974
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2025-10-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184504
Hyphenated Format 70518-4504

Supplemental Identifiers

RxCUI
809996
UNII
563KS2PQY5
NUI
N0000008486

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 ANDA204974 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4504-0)
  • 30 POUCH in 1 BOX (70518-4504-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-4504-2)
source: ndc

Packages (2)

70518-4504-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4504-0) 70518-4504-1 30 POUCH in 1 BOX (70518-4504-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-4504-2)

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": "49ebe440-0aef-da54-e063-6294a90a41cc", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["809996"], "spl_set_id": ["edd20b60-6265-4c4e-a95a-aaf8103cd852"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4504-0)", "package_ndc": "70518-4504-0", "marketing_start_date": "20251014"}, {"sample": false, "description": "30 POUCH in 1 BOX (70518-4504-1)  / 1 TABLET, FILM COATED in 1 POUCH (70518-4504-2)", "package_ndc": "70518-4504-1", "marketing_start_date": "20260202"}], "brand_name": "Lacosamide", "product_id": "70518-4504_49ebe440-0aef-da54-e063-6294a90a41cc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-4504", "dea_schedule": "CV", "generic_name": "lacosamide", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "200 mg/1"}], "application_number": "ANDA204974", "marketing_category": "ANDA", "marketing_start_date": "20251014", "listing_expiration_date": "20271231"}