lacosamide oral solution (71921-411)

Drug Facts

Product Profile

Brand Name lacosamide oral solution

Generic Name lacosamide oral

Labeler florida pharmaceutical products, llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

lacosamide 10 mg/mL

Manufacturer

Florida Pharmaceutical Products, LLC

Identifiers & Regulatory

Product NDC 71921-411

Product ID 71921-411_ceee316d-6ad9-4bca-9416-47ae954d174f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA220386

DEA Schedule cv

Listing Expiration 2027-12-31

Marketing Start 2026-01-30

Pharmacologic Class

Physiologic Effect

decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71921411

Hyphenated Format 71921-411

Supplemental Identifiers

RxCUI

993856

UPC

0371921411719

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 (source: ndc)

Application Number ANDA220386 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (71921-411-71) / 200 mL in 1 BOTTLE

source: ndc

Packages (1)

71921-411-71 1 BOTTLE in 1 CARTON (71921-411-71) / 200 mL in 1 BOTTLE

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": "ceee316d-6ad9-4bca-9416-47ae954d174f", "openfda": {"nui": ["N0000008486"], "upc": ["0371921411719"], "unii": ["563KS2PQY5"], "rxcui": ["993856"], "spl_set_id": ["ba4e2e28-7dc3-47b3-9c2c-34e0b1f39fb8"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71921-411-71)  / 200 mL in 1 BOTTLE", "package_ndc": "71921-411-71", "marketing_start_date": "20260130"}], "brand_name": "Lacosamide Oral Solution", "product_id": "71921-411_ceee316d-6ad9-4bca-9416-47ae954d174f", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71921-411", "dea_schedule": "CV", "generic_name": "Lacosamide Oral", "labeler_name": "Florida Pharmaceutical Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lacosamide Oral Solution", "active_ingredients": [{"name": "LACOSAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA220386", "marketing_category": "ANDA", "marketing_start_date": "20260130", "listing_expiration_date": "20271231"}