Chemical Structure (Lutera 01)
Lutera Kit
Product Images NDC 51862-028
View Photos of Packaging, Regulatory Labels, and Product Appearance
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.
Chemical Structure (Lutera 02)
Ethinyl Estradiol is a synthetic estrogen that is commonly used in combination with other drugs as a contraceptive. It works by suppressing ovulation, thickening cervical mucus to prevent sperm from reaching the egg, and altering the lining of the uterus to prevent implantation. Ethinyl Estradiol is also used in hormone replacement therapy and the treatment of certain menstrual disorders.*
Figure I (Lutera 03)
Figure Ii (Lutera 04)
This is a chart showing mortality rates per 100,000 woman-years based on age, smoking status, and oral contraceptive use for ever-users and controls (non-smokers and smokers). The chart shows a range from 0 to 150 and is adapted from a Lancet article published in 1981.*
Image (Lutera 05)
This text lists various studies conducted to determine the relationship between contraceptive use and certain health outcomes in women. The studies mentioned are the NICHD Women's Contraceptive Study (2002), the French E3N cohort study (2005), the Shanghai Women's Health Study (2009), the Nurses' Health Study I (2010), and the Oxford Family Planning Association Study (2013). The studies considered both ever use and current use of contraceptives. The text also includes some data presented in the format of Effect Estimate (OR/RR) for certain outcomes, but without contextual information it is challenging to determine its significance.*
Principal Display Panel (Kit Carton)
This is a prescription information sheet for Lutera® birth control pills. The sheet provides instructions on how to take the pills for three consecutive days from Thursday to Saturday. The medication is a combination of Lovonorgestral 0.1 mg and Ethinyl Estradiol 002 mg, and the tablets in the fourth week are inactive. The sheet also includes a product code (NOC: 51862-028-01) and an instruction to follow arrows.*
Lutera 07
This is a description of Lutera, a prescription medication that contains levonorgestrel and ethinyl estradiol. It comes in 28-day regimen tablets containing 21 active tablets with 0.1mg levonorgestrel and 0.02mg ethinyl estradiol and 7 inactive peach tablets. The medication is manufactured by Mayne Pharma and is only available through prescription. It should be stored at controlled room temperature (20-25°C). The package insert should be read for full details. The NDC for this medication is 51862-028-06.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
