Sotalol Hydrochloride
Product Images NDC 10135-717

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Sotalol Hydrochloride (NDC 10135-717). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Marlex Pharmaceuticals 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

Structural Formula (Sotalol Hydrochloride Tablets Af 01)

Chemical structure diagram of the active ingredient in Sotalol Hydrochloride AF, showing its molecular arrangement with a benzene ring, sulfonamide group, and side chains including an alcohol and amine hydrochloride moiety.*

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Figure 1 Study 1—time To First Ecg-documented Recurrence Of Symptomatic Afib/afl Since Randomization (Sotalol Hydrochloride Tablets Af 02)

A Kaplan-Meier survival curve graph comparing the proportions of patients remaining free of sustained ventricular tachycardia or ventricular fibrillation over time (days) for various doses of BETAPACE NF (80 mg, 120 mg, 160 mg) versus placebo. The plot shows four distinct survival curves indicating different event-free probabilities over approximately 330 days.*

FDA Label Image

Figure 2 Study 2 – Time To First Ecg-documented Recurrence Of Symptomatic Afib/afl/death Since Randomization (Sotalol Hydrochloride Tablets Af 03)

A Kaplan-Meier survival curve comparing treatment groups labeled Betapace AF and Placebo over time in days. The y-axis represents the proportion of patients free of the outcome being measured, and the x-axis represents time in days, with survival decreasing over the study period. A log-rank p-value of 0.002 is shown, indicating statistical comparison between the two groups.*

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Formula (Sotalol Hydrochloride Tablets Af 04)

A text panel showing formulas for calculating creatinine clearance in males and females. The formulas use age, body weight in kilograms, serum creatinine levels in mg/dL, and a correction factor (0.85) for females.*

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Graph (Sotalol Hydrochloride Tablets Af 05)

A chart depicting the Age Factor as a function of age in months plotted on a logarithmic scale. The curve shows an increasing trend of the Age Factor from approximately 0.1 at 0.1 months to nearly 1.0 by 60 months, illustrating changes observed over this age range.*

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Ndc 10135-0715-01 100 Tabletssotalol Hydrochloride Tablets, Usp (af)80 mgrx Only (Sotalol Hydrochloride Tablets Af 06)

Sotalol Hydrochloride AF 80 mg tablets label from Marlex Pharmaceuticals Inc. The label indicates 100 tablets per container. It includes storage instructions at 25°C with permitted excursions, a caution to keep medication out of reach of children, and notes the product is Rx only.*

FDA Label Image

Ndc 10135-0716-01100 Tabletssotalol Hydrochloride Tablets, Usp (af)120 mgrx Only (Sotalol Hydrochloride Tablets Af 07)

Label for Sotalol Hydrochloride AF Tablets, USP 120 mg by Marlex Pharmaceuticals Inc. The label states the product contains 100 tablets, is prescription only, and includes storage instructions at 25°C with permitted excursions. It also advises keeping medication out of children's reach and provides manufacturer details including location in New Castle, DE.*

FDA Label Image

Ndc 10135-0717-01100 Tabletssotalol Hydrochloride Tablets, Usp (af)160 mg Rx Only (Sotalol Hydrochloride Tablets Af 08)

Label for Sotalol Hydrochloride AF 160 mg tablets by Marlex Pharmaceuticals Inc. The label displays the product name, strength of 160 mg, dosage form as tablets, and package size of 100 tablets. It includes directions to see accompanying literature for dosage and storage instructions, a barcode, and manufacturing information from Marlex Pharmaceuticals in New Castle, DE.*

* 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.