Betapace Tablet
Product Images NDC 83107-005

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Betapace (NDC 83107-005). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Legacy Pharma 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

Image Description (Betapace Tabs Graph 1)

A line graph depicting the relationship between Age Factor and Age in months for BETAPACE tablets. The x-axis represents Age in months on a logarithmic scale from 0.1 to 50, and the y-axis represents Age Factor, ranging from 0.0 to 1.0. The graph shows Age Factor increasing with age, approaching 1 for ages over 24 months.*

FDA Label Image

Image Description (Betapace Tabs Structure)

Chemical structure diagram of sotalol hydrochloride showing its molecular arrangement including a sulfonamide group, a benzene ring, and an amine side chain with a hydrochloride component.*

FDA Label Image

Image Description (Betapace Tabs Graph 2)

A Kaplan-Meier survival curve chart comparing recurrence-free survival over time (days) among oral sotalol tablet doses (80 mg, 120 mg, 160 mg) versus placebo. The chart shows survival probabilities decreasing over 360 days and includes log-rank p-values for each sotalol dose compared to placebo.*

FDA Label Image

Image Description (Betapace Tabs Graph 3)

A line chart comparing recurrence-free survival over time (days) between BETAPACE AF (oral sotalol) and placebo groups. The vertical axis represents recurrence-free survival from 0.0 to 1.0, and the horizontal axis spans up to 180 days, marking study completion. The BETAPACE AF group shows higher survival rates compared to placebo. A p-value of 0.002 from the log-rank test is noted, indicating statistical comparison.*

FDA Label Image

Image Description (Betapace Legacy Logo)

FDA Label Image

Image Description (Betapace Tabs 80mg 100s Bottle Label)

Betapace 80 mg oral tablets label showing that each tablet contains 80 mg of sotalol hydrochloride. The label includes storage instructions to keep at 25°C (77°F) with permitted excursions and directs to see the package insert for dosage information. The product is labeled for dispensing in a well-closed container and manufactured by Legacy Pharma USA, Inc., with the product made in Spain. The package contains 100 tablets.*

FDA Label Image

Image Description (Betapace Tabs 120mg 100s Bottle Label)

Label for Betapace (sotalol hydrochloride) 120 mg oral tablets, containing 100 tablets. The label includes storage instructions, dosage note to see package insert, manufacturer Legacy Pharma USA, Inc., and indicates the product is Rx only. Made in Spain with revision date 8/24.*

FDA Label Image

Image Description (Betapace Tabs 160mg 100s Bottle Label)

Label for Betapace (sotalol HCl) oral tablets, 160 mg strength, containing 100 tablets. The label includes dosage instructions referencing the package insert, storage conditions at 25°C with permitted excursions, and dispensing requirements. Manufactured for Legacy Pharma Inc., Georgetown, Grand Cayman, and made in Spain. The Legacy Pharma logo is present on the label.*

FDA Label Image

Image Description (Betapace Af Tabs 80mg 60s Bottle Label)

BETAPACE AF 80 mg tablet label containing sotalol hydrochloride for oral use. The label indicates a 60 tablet unit of use package, manufactured by Legacy Pharma USA, Inc. It includes dosing instructions to follow physician directions and storage information (store at 25°C with permitted excursions). The label notes it is prescription only and made in Spain.*

FDA Label Image

Image Description (Betapace Af Tabs 120mg 60s Bottle Label)

Label for BETAPACE AF 120 mg tablets, containing sotalol hydrochloride, in a patient pack of 60 tablets. The label includes dosage instructions to take as prescribed, storage conditions, and manufacturer information for Legacy Pharma Inc., made in Spain.*

FDA Label Image

Image Description (Betapace Af Tabs 160mg 60s Bottle Label)

Label for BETAPACE AF 160 mg tablet, containing sotalol hydrochloride, in a 60-tablet unit of use. The label includes dosage instructions to take as prescribed by a physician, storage conditions, the NDC number 83107-010-60, and the manufacturer Legacy Pharma USA, Inc., with manufacturing in Spain. The label features the Legacy Pharma logo and specifies the product as 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.