lacosamide

Generic: lacosamide

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide
Generic Name lacosamide
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lacosamide 200 mg/20mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-4048
Product ID 0121-4048_80024eb8-f6ab-420a-94df-dc5dd9ffb9b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216151
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-08-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01214048
Hyphenated Format 0121-4048

Supplemental Identifiers

RxCUI
993856
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 ANDA216151 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/20mL
source: ndc
Packaging
  • 1 TRAY in 1 CASE (0121-4048-95) / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (0121-4048-74)
source: ndc

Packages (1)

0121-4048-95 1 TRAY in 1 CASE (0121-4048-95) / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (0121-4048-74)

Ingredients (1)

lacosamide (200 mg/20mL)

Linked Drug Pages (1)

Lacosamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "80024eb8-f6ab-420a-94df-dc5dd9ffb9b3", "openfda": {"nui": ["N0000008486"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["75de00d8-d2e7-4025-be4e-f49299068e7e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CASE (0121-4048-95)  / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (0121-4048-74)", "package_ndc": "0121-4048-95", "marketing_start_date": "20220826"}], "brand_name": "Lacosamide", "product_id": "0121-4048_80024eb8-f6ab-420a-94df-dc5dd9ffb9b3", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0121-4048", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "200 mg/20mL"}], "application_number": "ANDA216151", "marketing_category": "ANDA", "marketing_start_date": "20220826", "listing_expiration_date": "20261231"}