lacosamide oral solution (67877-732)

Drug Facts

Product Profile

Brand Name lacosamide oral solution

Generic Name lacosamide oral solution

Labeler ascend laboratories, llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

lacosamide 10 mg/mL

Manufacturer

Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-732

Product ID 67877-732_c4d07291-0152-4092-a339-3edee132ef09

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214672

DEA Schedule cv

Listing Expiration 2026-12-31

Marketing Start 2022-05-20

Pharmacologic Class

Physiologic Effect

decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877732

Hyphenated Format 67877-732

Supplemental Identifiers

RxCUI

993856

UPC

0367877732954

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 oral solution (source: ndc)

Application Number ANDA214672 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

200 mL in 1 BOTTLE (67877-732-95)
465 mL in 1 BOTTLE (67877-732-97)

source: ndc

Packages (2)

67877-732-95 200 mL in 1 BOTTLE (67877-732-95) 67877-732-97 465 mL in 1 BOTTLE (67877-732-97)

Ingredients (1)

lacosamide (10 mg/mL)

Linked Drug Pages (1)

Lacosamide Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "c4d07291-0152-4092-a339-3edee132ef09", "openfda": {"nui": ["N0000008486"], "upc": ["0367877732954"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["4ae87834-05d8-43c8-aaa3-78047d4a573c"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 mL in 1 BOTTLE (67877-732-95)", "package_ndc": "67877-732-95", "marketing_start_date": "20220520"}, {"sample": false, "description": "465 mL in 1 BOTTLE (67877-732-97)", "package_ndc": "67877-732-97", "marketing_start_date": "20220520"}], "brand_name": "Lacosamide Oral Solution", "product_id": "67877-732_c4d07291-0152-4092-a339-3edee132ef09", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "67877-732", "dea_schedule": "CV", "generic_name": "Lacosamide Oral Solution", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide Oral Solution", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA214672", "marketing_category": "ANDA", "marketing_start_date": "20220520", "listing_expiration_date": "20261231"}