Simpesse Kit
Product Images NDC 65862-864

View Photos of Packaging, Regulatory Labels, and Product Appearance

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.

Product Images & Figures Index

FDA Label Image

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

Figure 1. Percent Of Women Taking Simpesse Who Reported Unscheduled Bleeding And/or Spotting Or Only Unscheduled Bleeding (Levonorethinyl Fig1)
The figure shows the percentage of women taking Simpesse who reported unscheduled bleeding and/or spotting or only unscheduled bleeding. The percentage ranges from 80% to 0% on the Y-axis while the X-axis shows the duration of the cycle from days 1 to 364. Cycle 1 to Cycle 4 is shown with their respective duration sub-intervals. The data is collected from 758 women for Cycle 1, 625 women for Cycle 2, 533 women for Cycle 3, and 446 women for Cycle 4.*
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Figure2 (Levonorethinyl Fig2)

Figure2 (Levonorethinyl Fig2)
This is a collection of results from various studies that compare the use of oral contraceptives containing ethynodiol diacetate (Ever GOC) and those containing norethindrone or levonorgestrel (Never COC). The studies mentioned are NICHD Women's Care Study, French EN cohort Study, Shanghai Women's Health Study, The Nurses Heath Sty I, Oxford Family Planning Study, and Darish Sex Hormone Regiser Stcy. The results are presented as odds ratios (OR), relative risks (RR), and hazard ratios (HR). The data seem to suggest that the risk of certain health outcomes may vary between the two types of contraceptives, but without further context or information, it is difficult to draw definitive conclusions.*
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Figure 3 (Levonorethinyl Fig3)

Figure 3 (Levonorethinyl Fig3)
This text provides information on the different types of birth control methods and their effectiveness in preventing pregnancy, ranging from fewer than 1 pregnancy per 100 women in one year to 85 or more pregnancies per 100 women in one year. The text displays various birth control options such as implants, injections, intrauterine devices, sterilization, birth control pills, skin patches, vaginal rings with hormones, condoms, diaphragm, spermicide, withdrawal, and no birth control.*
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Package Label-principal Display Panel (0.15 mg/0.03 mg and 0.01 mg (91 Tablets Pouch))

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

Package Label-principal Display Panel (0.15 mg/0.03 mg and 0.01 mg (2 x 91 Tablets Carton))
This is a description of a contraceptive product called Simpesse. The NDC number and the constituents of the tablets are included. The product is intended to prevent pregnancy but does not protect against sexually transmitted diseases. The product comes in a pack of 91 tablets, including one extended cycle wallet containing 84 tablets and seven light blue tablets. The text also includes the manufacturer's name, address, and country of origin.*
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Levonorethinyl Fig6

Levonorethinyl Fig6
Simpesse is a prescription medication containing levonorgestrel and ethinyl estradiol. It comes in two extended-cycle wallets, with each containing 91 tablets. The tablets are white and light blue, with the white ones containing 0.15 mg levonorgestrel USP and 0.03 mg ethinyl estradiol USP, while the light blue ones contain 0.01 mg ethinyl estradiol USP. This medication is used once daily for 91 consecutive days. It is child-resistant and should be kept out of reach of children. Simpesse does not protect against pregnancy or sexually transmitted diseases. The recommended storage temperature is from 20 to 25 degrees Celsius.*
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Levonorgestrel Chemical Structure (Levonorethinyl Str1)

Levonorgestrel Chemical Structure (Levonorethinyl Str1)
Levonorgestrel is a chemical compound with the molecular formula CuHxO and MW of 3124. No further information is available to provide a more useful description.*
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Ethinyl Estradiol Chemical Structure (Levonorethinyl Str2)

Ethinyl Estradiol Chemical Structure (Levonorethinyl Str2)
Ethinyl estradiol is a synthetic estrogen that is commonly used in combination with progestin as a component of hormonal contraceptives. The text seems to be providing information on its chemical formula and molecular weight, CuH:.0; MW:2964.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.