Betapace
Product Images NDC 70515-106

11 FDA label images from Covis Pharma Us, Inc · 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 Betapace (NDC 70515-106). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Covis Pharma Us, 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 (Image 01)

Figure 1 (Image 01)
A line graph depicting the relationship between age in months (x-axis) and age factor (y-axis) for BETAPACE. The x-axis ranges from 0.1 to over 50 months, and the y-axis ranges from 0 to 1. The curve rises steeply from near 0 at 0.1 months to near 1 at approximately 24 months, indicating the age factor approaches 1 after 24 months.*
FDA Label Image

Structural Formula (Image 02)

Structural Formula (Image 02)
Chemical structure diagram showing the molecular formula of the active ingredient contained in BETAPACE, including sulfonamide and hydrochloride functional groups.*
FDA Label Image

Figure 2 (Image 03)

Figure 2 (Image 03)
A Kaplan-Meier survival curve chart comparing recurrence-free survival over time (days) for oral Sotalol at doses of 80 mg, 120 mg, 160 mg, and placebo. The graph shows survival probability on the y-axis and time in days on the x-axis, with p-values from Log-Rank tests listed for each dose versus placebo.*
FDA Label Image

Figure 3 (Image 04)

Figure 3 (Image 04)
A Kaplan-Meier survival curve comparing recurrence-free survival over time (days) between oral Sotalol and placebo groups. The y-axis represents recurrence-free survival probability, and the x-axis shows time in days up to 180. BETAPACE AF and Placebo groups are plotted, with a log-rank p-value of 0.002 indicating statistical comparison.*
FDA Label Image

Covis Logo (Image 05)

FDA Label Image

Principal Display Panel (80 mg Betapace)

Principal Display Panel (80 mg Betapace)
Betapace 80 mg tablets packaging label displaying sotalol hydrochloride as the active ingredient. The label indicates a quantity of 100 tablets, with storage and dispensing instructions. Manufactured for Covis Pharma US, Inc. The label includes a barcode and batch and expiration date information.*
FDA Label Image

Principal Display Panel (120 mg Betapace)

Principal Display Panel (120 mg Betapace)
Label for Betapace (sotalol HCl) 120 mg tablets, containing 100 tablets. The label states the active ingredient amount, storage instructions, and manufacturer information for Covis Pharma US, Inc. It includes dosage directions to see the package insert and mentions dispensing requirements. The product is made in Spain.*
FDA Label Image

Principal Display Panel (160 mg Betapace)

Principal Display Panel (160 mg Betapace)
Betapace 160 mg tablet label with active ingredient sotalol hydrochloride. The label shows a package size of 100 tablets and includes storage instructions at 25°C with permitted excursions. Manufactured for Covis Pharma US, Inc., with additional details including batch and expiration date.*
FDA Label Image

Principal Display Panel (80 mg Betapace AF)

Principal Display Panel (80 mg Betapace AF)
BETAPACE AF 80 mg tablet label featuring sotalol hydrochloride as the active ingredient. The label indicates a patient pack containing 60 tablets, manufactured for Covis Pharma US, Inc., with storage instructions and prescribing notes included. The label also shows batch number and expiration date details, along with a Covis logo.*
FDA Label Image

Principal Display Panel (120 mg Betapace AF)

Principal Display Panel (120 mg Betapace AF)
Label for BETAPACE AF containing 120 mg sotalol hydrochloride per tablet in a patient pack of 60 tablets. Manufactured for Covis Pharma US, Inc., with manufacturing in Spain and packaging from Covis Pharma Zug, Switzerland. The label includes storage instructions, prescribing advice, and batch and expiration dates.*
FDA Label Image

Principal Display Panel (160 mg Betapace AF)

Principal Display Panel (160 mg Betapace AF)
BETAPACE AF 160 mg tablet patient pack label showing sotalol hydrochloride as active ingredient. The label indicates a package of 60 tablets, manufactured for Covis Pharma US, Inc., printed with storage instructions, batch number, and expiration date. The label includes dosage guidance to follow physician instructions and storage at controlled room temperature.*

* 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.