Varenicline
Product Images NDC 0378-5089

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Varenicline (NDC 0378-5089). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan 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

Varenicline Tablets 0.5 mg Bottle Label (Image 01)

Label for Varenicline Tablets 0.5 mg manufactured for Mylan Pharmaceuticals Inc. The label states each tablet contains 0.855 mg varenicline tartrate equivalent to 0.5 mg varenicline free base, with dosage and storage instructions. The package contains 56 tablets and includes barcodes, labeling for prescription use only, and instructions to dispense the accompanying medication guide.*

FDA Label Image

Varenicline Tablets 1 mg Bottle Label (Image 02)

Label for Varenicline tablets, 1 mg strength, manufactured for Mylan Pharmaceuticals Inc. The label includes dosage information, storage instructions, a barcode, and a note to dispense the accompanying Medication Guide. The package contains 56 film-coated tablets and is marked "Rx only." The label also displays NDC 0378-5090-73 and safety information about container closure and variable data coding.*

FDA Label Image

Varenicline Tartrate Structural Formula (Image 03)

Chemical structure depicting the active ingredient Varenicline as submitted by Mylan Pharmaceuticals Inc. The structure includes a bicyclic heteroaromatic compound bound to an organic acid moiety, shown with skeletal formula and functional groups.*

FDA Label Image

Figure 1: Continuous Abstinence, Weeks 9 Through 12 (Image 04)

A bar chart comparing the effectiveness of various dosages and formulations of Varenicline, placebo, and Bupropion SR across five different study groups. The vertical axis represents percentage values, showing variations in response rates among treatments labeled by dosage and study number.*

FDA Label Image

Figure 2: Continuous Abstinence, Weeks 9 Through 52 (Image 05)

A bar chart displaying percentage results across five studies comparing Varenicline, Bupropion SR, and placebo groups. The x-axis shows different study groups with treatment names and doses, while the y-axis represents percentage values from 0% to 35%. Each bar includes error bars indicating variability.*

FDA Label Image

Figure 3: Continuous Abstinence Rate During Nontreatment Follow-up (Image 06)

Line graph comparing the percentage of continuous abstinent subjects over nontreatment follow-up in weeks for Varenicline 1.0 mg BID versus placebo. The graph shows higher abstinence rates for Varenicline throughout the follow-up period, with data points marked for both groups.*

FDA Label Image

Varenicline Tablets 0.5 mg And 1 mg Carton Label (Image 07)

Box packaging label for Varenicline tablets by Mylan Pharmaceuticals Inc. featuring two strengths: 0.5 mg and 1 mg. The label indicates this is a starting month box for the first 4 weeks, containing one week of 0.5 mg tablets and three weeks of 1 mg tablets. Dosage instructions and storage conditions are also present.*

* 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.