Simpesse Kit
Product Images NDC 65862-864

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Simpesse (NDC 65862-864). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure 1. Percent Of Women Taking Simpesse Who Reported Unscheduled Bleeding And/or Spotting Or Only Unscheduled Bleeding (Levonorethinyl Fig1)

A bar chart illustrating the percent of women taking Simpesse who reported unscheduled bleeding and/or spotting or only unscheduled bleeding across four cycles. The x-axis shows four cycles with day ranges and sample sizes, and the y-axis shows percent from 0% to 80%. Each cycle has two bars: a hollow bar for bleeding and/or spotting, and a striped bar for bleeding only, with percentage values indicated atop each bar.*

FDA Label Image

Figure2 (Levonorethinyl Fig2)

A forest plot comparing the effect estimates (odds ratios, relative risks, and hazard ratios) of combined oral contraceptive (COC) use versus never use across several studies, including the NICHD Women's Care Study, French E3N cohort, Shanghai Women's Health Study, Nurses' Health Study, Oxford Family Planning Study, and Danish Sex Hormone Register Study. The plot displays point estimates with confidence intervals along an effect estimate axis ranging from -1.5 to 2.0.*

FDA Label Image

Figure 3 (Levonorethinyl Fig3)

A chart illustrating pregnancy rates associated with various birth control methods, ranging from fewer than 1 pregnancy per 100 women per year for implants, injections, intrauterine devices, and sterilization, to 85 or more pregnancies per 100 women per year with no birth control. Methods such as birth control pills, skin patches, and vaginal rings with hormones show fewer pregnancies compared to condoms and diaphragms, while behavioral methods like withdrawal and avoiding sex during fertile days show higher pregnancy rates.*

FDA Label Image

Package Label-principal Display Panel (0.15 mg/0.03 mg and 0.01 mg (91 Tablets Pouch))

Weekly pill tracking chart for Simpesse kit showing days of the week (Sunday to Saturday) and sequential weeks for pill intake. The chart includes three sections with empty circles to mark taken tablets. The bottom text lists the active ingredients and their strengths: levonorgestrel 0.15 mg, ethinyl estradiol 0.03 mg, and ethinyl estradiol 0.01 mg.*

FDA Label Image

Package Label-principal Display Panel (0.15 mg/0.03 mg and 0.01 mg (2 x 91 Tablets Carton))

Packaging label for Simpesse kit by Aurobindo Pharma Limited, containing levonorgestrel and ethinyl estradiol tablets. The label specifies the active ingredients' strengths (0.15 mg levonorgestrel, 0.03 mg ethinyl estradiol, and 0.01 mg ethinyl estradiol) in an extended-cycle wallet with 91 tablets total. The label includes usage instructions, storage information, and manufacturer details.*

FDA Label Image

Levonorethinyl Fig6

Simpesse kit packaging label by Aurobindo Pharma Limited contains 2 extended-cycle wallets with 91 tablets each. The product includes levonorgestrel and ethinyl estradiol tablets USP 0.15 mg/0.03 mg and ethinyl estradiol tablets USP 0.01 mg. The label shows dosage information, storage instructions, and safety warnings, with product identification codes visible.*

FDA Label Image

Levonorgestrel Chemical Structure (Levonorethinyl Str1)

Chemical structure of Levonorgestrel, showing its molecular formula C21H28O2 and molecular weight 312.4. The diagram depicts the steroid backbone with hydroxyl and ketone functional groups.*

FDA Label Image

Ethinyl Estradiol Chemical Structure (Levonorethinyl Str2)

Chemical structure of Ethinyl Estradiol with molecular formula C20H24O2 and molecular weight 296.4 is displayed in the image.*

* 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.