Varenicline Tablet, Film Coated
Product Images NDC 75834-335

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Varenicline (NDC 75834-335). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nivagen 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

Chemical-structure (Image 01)

Chemical structure of varenicline depicted with functional groups including hydroxyl, carboxyl, and a bicyclic nitrogen-containing ring system.*

FDA Label Image

Figure-1 (Image 02)

A bar chart comparing the effects of varenicline tablets at different dosages and regimens versus placebo and bupropion SR 150 mg BID across four studies labeled Study 2, Study 3, Study 4, and Study 5. The vertical axis represents percentage ranging from 0% to 60%. Each study includes bars for varenicline tablets (various dosages), placebo, and in some cases bupropion SR, with error bars showing variability.*

FDA Label Image

Figure-2 (Image 03)

A multi-panel bar chart comparing percentages across four studies labeled Study 2 to Study 5. Each panel displays bars for varenicline tablets at various dosages (.5 mg BID, 1.0 mg BID, and flexible), bupropion SR 150 mg BID (in Studies 4 and 5), and placebo groups. The vertical axis represents percentages from 0% to 35%, with error bars shown for each group.*

FDA Label Image

Figure-3 (Image 04)

A line graph depicting the percentage of continuous abstinent participants over nontreatment follow-up weeks comparing varenicline tablets 1.0 mg BID and placebo groups. The y-axis shows % continuous abstinent from 0 to 100, and the x-axis shows weeks from 25 to 52. The varenicline group maintains higher abstinence rates than placebo throughout the follow-up period.*

FDA Label Image

Image-05.jpg (Image 05)

Varenicline tablets packaging label from Nivagen Pharmaceuticals Inc. The box is for a starting month supply containing 3 starting week tablets (0.5 mg each, 11 tablets) and 3 continuing weeks (1 mg each, 42 tablets). The label instructs to use the green box first when beginning treatment and includes dosing instructions and storage conditions. Tablets are film-coated oral dosage form.*

FDA Label Image

Image-06.jpg (Image 06)

Varenicline Tablets continuing month box carton from Nivagen Pharmaceuticals Inc. Label indicates a 4-week supply with four blister cards containing 14 tablets each (total 56 tablets), dosed at 1 mg strength. Instructions to dispense the enclosed Medication Guide are visible, along with dosage guidance and storage conditions. NDC 75834-335-27 is printed on the box.*

FDA Label Image

Image-07.jpg (Image 07)

Varenicline Tablets 0.5 mg film-coated tablet packaging label from Nivagen Pharmaceuticals Inc. The label includes the NDC number 75834-334-28, a statement to dispense the enclosed medication guide to each patient, and indicates a pack size of 56 tablets. Storage instructions and dosage directions note the active ingredient content as 0.5 mg varenicline free base per tablet.*

FDA Label Image

Image-08.jpg (Image 08)

Varenicline Tablets 1 mg film-coated oral tablets label by Nivagen Pharmaceuticals Inc. The label states the quantity as 56 tablets and includes storage instructions, dosage directions referencing accompanying prescribing information, and a note to dispense an enclosed medication guide. A barcode and NDC number 75834-335-28 are visible on the label.*

* 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.