Sotalol Hydrochloride Tablet
Product Images NDC 76385-127

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Sotalol Hydrochloride (NDC 76385-127). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unichem Pharmaceuticals (usa), Inc., 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

Figure-1 (Figure 1)

A line chart showing the relationship between age in months (x-axis) and age factor (y-axis). The age factor increases steeply from near 0 at 0.1 months to 1.0 at about 24 months and remains at 1.0 thereafter. The chart includes a note indicating that the age factor equals 1 for ages greater than 24 months.*

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Structure (Structure)

Chemical structure of Sotalol Hydrochloride, showing its molecular formula with a benzene ring, sulfonamide group, and side chain including hydroxyl and amine groups.*

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Figure2 (Figure2)

A line graph titled "Study 1 – Time to First ECG-Documented Recurrence of Symptomatic AFIB/AFL Since Randomization" showing recurrence-free survival over time (days up to 360) for Oral Sotalol at doses of 80 mg, 120 mg, and 160 mg compared to placebo. The graph includes p-values for comparisons between Sotalol doses and placebo, indicating statistical differences in recurrence rates.*

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Figure3 (Figure3)

A Kaplan-Meier survival curve chart comparing recurrence-free survival over time (up to 180 days) between oral Sotalol treatment and placebo. The y-axis represents recurrence-free survival probability, while the x-axis shows time in days. The Sotalol group shows higher survival probability than placebo, with a p-value of 0.002 indicating statistical significance.*

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80mg-label (80mg Label)

Label for Sotalol Hydrochloride Tablets, USP 80 mg oral tablets. The label states each tablet contains 80 mg of sotalol hydrochloride, and it is dispensed in a well-closed container. Distributed by Bayshore Pharmaceuticals LLC, Short Hills, NJ. Manufactured by Beximco Pharmaceuticals Ltd, Gazipur, Bangladesh. The package contains 100 tablets and is for prescription use only.*

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120mg-label (120mg Label)

Label for Sotalol Hydrochloride Tablets USP 120 mg, indicating 100 tablets per container. The product is distributed by Bayshore Pharmaceuticals LLC and manufactured by Beximco Pharmaceuticals Ltd. The label includes storage instructions and a barcode, with the proprietary and generic names prominently displayed.*

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160mg-label (160mg Label)

Label for Sotalol Hydrochloride Tablets USP 160 mg. The label states the product contains 160 mg of sotalol hydrochloride per tablet. It is distributed by Bayshore Pharmaceuticals LLC and manufactured by Beximco Pharmaceuticals Ltd. The container holds 100 tablets. Storage instructions indicate keeping at 25°C (77°F) with permitted excursions between 15°C to 30°C (59°F to 86°F). It is for prescription use only.*

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Af-80mg-label (Af 80mg Label)

Label for Sotalol Hydrochloride Tablets USP (AF) 80 mg by Unichem Pharmaceuticals (USA), Inc. The label states each tablet contains 80 mg of sotalol hydrochloride. It includes dosage instructions, storage conditions, and manufacturing information by Beximco Pharmaceuticals PLC, Bangladesh. The package contains 100 tablets for oral use, prescription only.*

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Af-120mg-label (Af 120mg Label)

Label for Sotalol Hydrochloride Tablets USP (AF) 120 mg by UNICHEM PHARMACEUTICALS (USA), INC. The label includes dosage form as oral tablets, a quantity of 100 tablets, and storage instructions. It also lists manufacturing by BEXIMCO PHARMACEUTICALS PLC in Bangladesh and distribution by Unichem Pharmaceuticals USA.*

FDA Label Image

Af-160mg-label.jpg (Af 160mg Label)

Label for Sotalol Hydrochloride Tablets USP (AF) 160 mg, oral tablets, with a count of 100 tablets. Manufactured by Beximco Pharmaceuticals PLC, Bangladesh, and distributed by Unichem Pharmaceuticals (USA), Inc. The label includes storage instructions and a barcode. It is marked Rx only.*

* 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.