lacosamide oral solution (82983-427)

Drug Facts

Product Profile

Brand Name lacosamide oral solution

Generic Name lacosamide

Labeler ajenat pharmaceuticals llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

lacosamide 10 mg/mL

Manufacturer

Ajenat Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 82983-427

Product ID 82983-427_9fd5f392-f470-4f19-96da-582fae4da496

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA219699

DEA Schedule cv

Listing Expiration 2026-12-31

Marketing Start 2025-07-14

Pharmacologic Class

Physiologic Effect

decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82983427

Hyphenated Format 82983-427

Supplemental Identifiers

RxCUI

993856

UPC

0382983427310

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 ANDA219699 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

200 mL in 1 BOTTLE, PLASTIC (82983-427-31)

source: ndc

Packages (1)

82983-427-31 200 mL in 1 BOTTLE, PLASTIC (82983-427-31)

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": "9fd5f392-f470-4f19-96da-582fae4da496", "openfda": {"nui": ["N0000008486"], "upc": ["0382983427310"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["cb29da34-89aa-405a-8fbc-2308bda37187"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Ajenat Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 mL in 1 BOTTLE, PLASTIC (82983-427-31)", "package_ndc": "82983-427-31", "marketing_start_date": "20250714"}], "brand_name": "Lacosamide Oral Solution", "product_id": "82983-427_9fd5f392-f470-4f19-96da-582fae4da496", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "82983-427", "dea_schedule": "CV", "generic_name": "Lacosamide", "labeler_name": "Ajenat Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide Oral Solution", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA219699", "marketing_category": "ANDA", "marketing_start_date": "20250714", "listing_expiration_date": "20261231"}