Varenicline Tablet, Film Coated
Product Images NDC 53401-032

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Varenicline (NDC 53401-032). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

Product Images & Figures Index

FDA Label Image

Label (53401 0032 84)

Label (53401 0032 84)
Varenicline 1 mg film-coated tablets packaging label showing the product name, strength, quantity of 1008 tablets, and storage instructions. The label indicates the drug is manufactured by Apotex Inc., Toronto, Ontario, and repackaged by Aphena Pharma Solutions in Cookeville, TN. The NDC number 53401-032-84 is also displayed along with warnings to keep out of reach of children and dispense in a tight light-resistant container.*
FDA Label Image

Aphena (Aphena)

Aphena (Aphena)
FDA Label Image

Figure-1 (Figure 1)

Figure-1 (Figure 1)
A bar chart titled 'Continuous Abstinence, Weeks 9 through 12' showing comparative percentages across five studies. Each study compares Varenicline at various dosages with placebo and other treatments, illustrating rates of continuous abstinence with error bars indicating variability. The vertical axis ranges from 0% to 60%, and treatment groups and study numbers are labeled on the horizontal axis.*
FDA Label Image

Figure-2 (Figure 2)

Figure-2 (Figure 2)
A bar chart titled 'Continuous Abstinence, Weeks 9 through 52' displaying comparative abstinence rates across five studies. The x-axis lists treatments including Varenicline at various doses and regimens, Bupropion SR 150 mg Bid, and Placebo, while the y-axis indicates percentage abstinence from 0% to 35%. Bars show higher abstinence rates for Varenicline and Bupropion compared to Placebo.*
FDA Label Image

Figure-3 (Figure 3)

Figure-3 (Figure 3)
A line graph comparing the percentage of continuous abstinent patients over multiple weeks of nontreatment follow-up between Varenicline 1.0 mg administered twice daily and placebo. The x-axis shows weeks of follow-up, and the y-axis represents the percentage of patients maintaining abstinence, with Varenicline consistently showing higher abstinence rates than placebo.*
FDA Label Image

Structure-1 (Structure 1)

Structure-1 (Structure 1)
Chemical structure of varenicline, the active ingredient. The diagram shows the molecular framework including a bicyclic system and a pyridine ring, as well as functional groups including amine and hydroxyl components.*

* 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.