lacosamide oral solution

Generic: lacosamide

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lacosamide oral solution
Generic Name lacosamide
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lacosamide 10 mg/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-885
Product ID 62135-885_2df7ee04-2970-8b37-e063-6294a90a29a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215154
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135885
Hyphenated Format 62135-885

Supplemental Identifiers

RxCUI
993856
UPC
0362135885229
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 oral solution (source: ndc)
Generic Name lacosamide (source: ndc)
Application Number ANDA215154 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 200 mL in 1 BOTTLE (62135-885-22)
  • 2 TRAY in 1 BOX (62135-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-885-10)
  • 2 TRAY in 1 BOX (62135-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-885-05)
source: ndc

Packages (3)

Ingredients (1)

lacosamide (10 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2df7ee04-2970-8b37-e063-6294a90a29a4", "openfda": {"nui": ["N0000008486"], "upc": ["0362135885229"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["7197c0b6-5bb9-43b3-be1d-e7615629df9a"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 mL in 1 BOTTLE (62135-885-22)", "package_ndc": "62135-885-22", "marketing_start_date": "20241127"}, {"sample": false, "description": "2 TRAY in 1 BOX (62135-885-23)  / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-885-10)", "package_ndc": "62135-885-23", "marketing_start_date": "20250210"}, {"sample": false, "description": "2 TRAY in 1 BOX (62135-885-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-885-05)", "package_ndc": "62135-885-24", "marketing_start_date": "20250210"}], "brand_name": "Lacosamide Oral Solution", "product_id": "62135-885_2df7ee04-2970-8b37-e063-6294a90a29a4", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "62135-885", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide Oral Solution", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA215154", "marketing_category": "ANDA", "marketing_start_date": "20240515", "listing_expiration_date": "20261231"}