Sotalol Hydrochloride Tablet
Product Images NDC 60505-0159

11 FDA label images from Apotex Corp. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Sotalol Hydrochloride (NDC 60505-0159). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

120mg100s

120mg100s
Sotalol Hydrochloride Tablets USP 120 mg label by Apotex Corp. The label shows a package containing 100 tablets. Storage instructions specify 20° to 25°C with permitted excursions to 15° to 30°C. The label includes the NDC 60505-0159-0 and manufacturer information for Apotex Corp. in Toronto, Ontario, and Weston, Florida.*
FDA Label Image

120mg100saf

120mg100saf
Label for Sotalol Hydrochloride Tablets, USP (AF) 120 mg by Apotex Corp. The package contains 100 tablets. Storage instructions specify keeping at 20° to 25°C. The label advises dispensing in a tight, light-resistant container and includes a pharmacist instruction to provide the enclosed patient information leaflet.*
FDA Label Image

160mg100s

160mg100s
Label for Sotalol Hydrochloride Tablets, USP, 160 mg strength, with a package count of 100 tablets. The label shows dosage information, storage instructions, and is labeled with NDC 60505-0081-0. Manufactured by Apotex Corp., with addresses in Toronto, Ontario, Canada, and Weston, Florida. Includes the Apotex Corp. logo and a barcode.*
FDA Label Image

160mg100saf

160mg100saf
Label for Sotalol Hydrochloride Tablets, USP (AF) 160 mg by Apotex Corp. The label indicates a package size of 100 tablets, with storage instructions at 20 to 25°C (68 to 77°F). It includes directions to dispense in a light-resistant container and notes that the dosage information is in the package insert. The label features a barcode and manufacturer information for Apotex Inc., Toronto, Ontario, Canada, and Apotex Corp., Weston, Florida.*
FDA Label Image

240mg100s

240mg100s
Label for Sotalol Hydrochloride Tablets, USP 240 mg by Apotex Corp. The label states each tablet contains 240 mg of sotalol hydrochloride and the package contains 100 tablets. Storage instructions and dispensing guidance are noted. The label includes the National Drug Code (NDC) 60505-0082-0, manufacturer details, and a barcode.*
FDA Label Image

80mg100s

80mg100s
Label for Sotalol Hydrochloride Tablets USP, 80 mg, containing 100 tablets. The label displays the drug name, strength, and dosage form prominently, with storage instructions and manufacturer information. The product is labeled by Apotex Corp., with NDC 60505-0080-0, including barcode and directions for dispensing in a light-resistant container.*
FDA Label Image

80mg100saf

80mg100saf
Label for Sotalol Hydrochloride Tablets, USP (AF) 80 mg by Apotex Corp. The label indicates a bottle containing 100 tablets. It includes storage instructions, a pharmacist note about dispensing an information leaflet, the NDC number 60505-0222-1, and the labeler's information for Apotex Inc. in Toronto, Ontario, Canada and Apotex Corp. in Weston, Florida.*
FDA Label Image

Figure

Figure
A graph depicting Age Factor versus Age in months, with Age Factor ranging from 0 to 1. The chart shows Age Factor increasing with Age, reaching 1 for ages greater than 24 months. The x-axis is logarithmically scaled from 0.1 to 50 months, illustrating the relationship between age and the corresponding age factor value.*
FDA Label Image

Figure2study1

Figure2study1
A line graph comparing recurrence-free survival over time in days for oral Sotalol at doses 80 mg, 120 mg, 160 mg, and placebo. The y-axis shows recurrence-free survival probability, and the x-axis shows time up to 360 days. The graph includes P-values for each dose versus placebo using the log-rank test.*
FDA Label Image

Figure3study2

Figure3study2
A Kaplan-Meier curve comparing recurrence-free survival over time (in days) between oral Sotalol Hydrochloride AF and placebo groups. The y-axis represents recurrence-free survival probability, and the x-axis shows time up to 180 days. The graph includes a P-value of 0.002 for the log-rank test comparing the two groups.*
FDA Label Image

Structurefigure

Structurefigure
Chemical structure of Sotalol Hydrochloride, showing its molecular composition including a benzene ring, sulfonamide group, hydroxyl group, and hydrochloride salt.*

* 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.