Carglumic Acid Tablet, For Suspension
Product Images NDC 35573-459

4 FDA label images from Burel Pharmaceuticals, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Carglumic Acid (NDC 35573-459). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Burel Pharmaceuticals, 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

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Chemical structure of carglumic acid, showing its molecular arrangement with amine, carboxyl, and hydroxyl groups.*
FDA Label Image

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Line graph depicting NH3 response in evaluable patients (n=13) over time. The x-axis shows days from Baseline through Day 7 and Long-term, while the y-axis represents Mean NH3 levels in µmol/L. The graph illustrates a sharp decline in NH3 levels from baseline to Day 2, followed by stabilization at lower levels through Long-term.*
FDA Label Image

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Label for Carglumic Acid Tablets for Oral Suspension, 200 mg, manufactured by Burel Pharmaceuticals, LLC. The label includes dosage and administration instructions, storage conditions, NDC 35573-459-60, a barcode, and a warning to keep out of reach of children. The package contains 60 tablets, Rx only.*
FDA Label Image

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Label panel for Carglumic Acid Tablets for Oral Suspension 200 mg by Burel Pharmaceuticals, LLC. The tablets are white to off-white, elongated, and scored for splitting. The label shows storage instructions, dosage reference to the package insert, packaging of 60 tablets, and notes to disperse tablets in water before use. Manufactured in India with directions for use and expiry tracking on the carton.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.