Lutera Kit
Product Images NDC 51862-028

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Lutera (NDC 51862-028). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mayne Pharma 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 (Lutera 01)

Chemical structure of levonorgestrel, the active ingredient in the prescription drug Lutera. The diagram shows the steroidal framework with functional groups typical of levonorgestrel.*

FDA Label Image

Chemical Structure (Lutera 02)

Chemical structure of ethinyl estradiol, a synthetic estrogen used in hormonal contraceptives and hormone therapy.*

FDA Label Image

Figure I (Lutera 03)

A dual line chart showing mean serum concentrations over time for levonorgestrel and ethinyl estradiol in 22 subjects receiving Lutera. The left graph plots levonorgestrel concentration (ng/mL) across 0 to 72 hours for days 1, 6, and 21. The right graph plots ethinyl estradiol concentration (pg/mL) over the same time points and days.*

FDA Label Image

Figure Ii (Lutera 04)

A bar chart showing circulatory disease mortality rates per 100,000 woman years categorized by age groups (15-24, 25-34, 35-44, 45+) and divided by smoking status and oral contraceptive use. The legend distinguishes between ever-users and controls, further separated into nonsmokers and smokers, with mortality rates increasing notably in older age groups, especially among ever-users who smoke.*

FDA Label Image

Image (Lutera 05)

A forest plot showing effect estimates (OR/RR) with confidence intervals from multiple studies related to contraceptive use. Studies from 2002 to 2017 are listed on the left, with effect estimates centered around the value 1 on the x-axis, which ranges from approximately -1.5 to 2. The plot visually compares results for ever use and current use of contraceptives across diverse cohort studies including NICHD, French E3N, Shanghai Women's Health, Nurses' Health, Oxford Family Planning, and Danish Sex Hormone Register studies.*

FDA Label Image

Principal Display Panel (Kit Carton)

Lutera oral contraceptive kit label showing a four-week daily tablet schedule arranged by day and week, indicating active tablets with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg. It includes arrows guiding tablet intake from Sunday through Saturday, with a note for monthly breast self-exam and inactive tablets in week four. Label identifies Mayne Pharma Inc. and includes NDC 51862-028-01.*

FDA Label Image

Lutera 07

Packaging label for Lutera levonorgestrel and ethinyl estradiol tablets USP, 28-day regimen. The label indicates each kit contains 6 blister cards with 28 tablets each, consisting of 21 white tablets and 7 peach inert tablets. Distributed by Mayne Pharma Inc., manufactured by Patheon Inc., with NDC 51862-028-06 shown. The label includes dosage indication and storage instructions.*

* 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.