Lacosamide Oral Solution
Product Images NDC 71921-411

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Lacosamide Oral Solution (NDC 71921-411). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Florida Pharmaceutical Products, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Lacosamide-carton (Lacosamide Carton)

Lacosamide-carton (Lacosamide Carton)
This is a product label providing information about Lacosamide Oral Solution, USP, containing 10 mg of lacosamide per mL. It includes details on the usual dosage, storage instructions, expiration date, and precautions for phenylketonurics. The medication guide is to be dispensed to each patient by the pharmacist. The product is manufactured by Indoco Remedies Ltd. in India and is distributed by Florida Pharmaceutical Products, LLC in Boca Raton, FL.*
FDA Label Image

Lacosamide-container (Lacosamide Container)

Lacosamide-container (Lacosamide Container)
Each mL of oral solution contains 10 mg of lacosamide, USP. The recommended dosage can be found in the package insert. Store between 20° to 25°C (68° to 77°F) and avoid freezing. The solution contains 0.005 mg phenylalanine per 200 mg dose. After opening, discard any unused product after six months. Keep out of reach of children and dispense in the original container. Attention pharmacists: Provide each patient with the Medication Guide. Manufactured by Indoco Remedies Ltd. for Florida Pharmaceutical Products, LLC. For inquiries, call toll-free 1-833-856-0880.*
FDA Label Image

Lacosamide-fig-1 (Lacosamide Fig 1)

Lacosamide-fig-1 (Lacosamide Fig 1)
The text provides information on the Median Percent Reduction in Seizure Frequency from Baseline to the Maintenance Phase by Dose. The data includes results from Study 2, Study 3, and Study 4, showing percentage reductions in seizure frequency. The comparison is made between placebo and Lacosamide at different doses (200mg, 400mg, 600mg). Statistically significant differences are noted, indicating the efficacy of Lacosamide in reducing seizures compared to placebo at specific doses.*
FDA Label Image

Lacosamide-fig-2 (Lacosamide Fig 2)

Lacosamide-fig-2 (Lacosamide Fig 2)
The text provides information on the Responder Rate for Lacosamide and Placebo groups in Studies 2, 3, and 4. It shows the proportions of patients by Responder Rate for different dosages of Lacosamide alongside the Placebo group. The data is organized in a chart displaying the percentages of patients falling within different categories of improvement or worsening.*
FDA Label Image

Lacosamide-fig-3 (Lacosamide Fig 3)

FDA Label Image

Lacosamide -structure (Lacosamide Structure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.