Nikki Kit
Product Images NDC 68180-886

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Nikki (NDC 68180-886). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin 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

Fig-1 (A30b8aed 1e92 49b7 9d4b 47adf6cec7c2 01)

The given text seems to be a list of different types of studies with their corresponding ratio values. The studies mentioned are Ingenix, EURAS, LASS, FDA-funded study, Danish, Danish re-analysis, MEGA study, German case-control, PharMetrics, and GPRD study. The types of studies listed are prospective and retrospective cohort studies, case-control studies, and non-fetal idiopathic cases only. There is also a chart with numbers ranging from 0.1 to 10.0. No further information about the context is provided.*

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Fig-2 (A30b8aed 1e92 49b7 9d4b 47adf6cec7c2 02)

This text provides ranges of blood clot incidents among women categorized by their pregnancy status and contraceptive use. Non-pregnant non-COC users have a blood clot rate of 103 per 10,000 WY while non-pregnant COC users have a rate of 3 to 109 per 10,000 WY. Postpartum women, up to 12 weeks, have a blood clot rate from 40 to 65 in 10,000 WY. The data on pregnancy is based on actual duration, with a rate range of 7 to 27 per 10,000 WY under the assumption of a nine-month term.*

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1 (A30b8aed 1e92 49b7 9d4b 47adf6cec7c2 03)

This is a collection of results from several studies assessing the relationship between the use of combined oral contraceptives (COCs) and certain health outcomes. The studies cited include NICHD Women's Care Study, French E3N cohort Study, Shanghai Women's Health Study, The Nurses' Health Study II, and the Oxford Family Planning Study. The results present the effect estimate for COC use compared to no use, in terms of relative risk (RR) or hazard ratio (HR), for different health outcomes. The last study mentioned, Danish Sex Hormone Register Study, does not provide readable information.*

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Fig-3 (A30b8aed 1e92 49b7 9d4b 47adf6cec7c2 04)

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Fig-4 (A30b8aed 1e92 49b7 9d4b 47adf6cec7c2 05)

This text is describing different methods of birth control and their effectiveness. It lists various forms of birth control such as implants, injections, intrauterine devices, sterilization, birth control pills, skin patch, vaginal rings with hormones, condoms, diaphragms, spermicide, withdrawal, and not having sex during the most fertile days of the monthly cycle. The text also highlights that there are varying rates of pregnancies per 100 women in one year depending on the type of birth control method used.*

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Fig-5 (A30b8aed 1e92 49b7 9d4b 47adf6cec7c2 06)

This is a description of a medication called Nikki. It is a tablet comprising of drospirenone and ethinyl estradiol in the ratio of 3mg/0.02mg respectively. The manufacturer appears to be Lupin. The text also contains a calendar with days of the week listed from Monday to Saturday. The rest of the information seems to be instructions on how to store the medication.*

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Fig-6 (A30b8aed 1e92 49b7 9d4b 47adf6cec7c2 07)

This text provides a table of ranges for non-pregnant COC users and non-COC users, as well as postpartum ranges for the first 12 weeks. It also includes a graph showing the number of women with blood clots out of 10,000 Women Years (WY). Pregnancy data is based on actual duration and estimates rates from 7 to 27 per 10,000 WY.*

FDA Label Image

Fig-7 (A30b8aed 1e92 49b7 9d4b 47adf6cec7c2 08)

This is a medical packaging label for Nikki tablets containing drospirenone and ethinyl estradiol. The tablets are stored at a temperature of 25°C, with excursions permitted to 15 to 30°C. The label indicates that the medication is distributed by Lupin Pharmaceuticals and manufactured by Lupin Limited in India. There is also a LOT NO. EXP number provided. The label includes instructions for a monthly self-breast exam. The rest of the text is not available or not readable.*

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Pouch (A30b8aed 1e92 49b7 9d4b 47adf6cec7c2 09)

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Carton (A30b8aed 1e92 49b7 9d4b 47adf6cec7c2 10)

This is a product description for a contraceptive pill called "drospirenone and ethinyl estradiol tablets USP", manufactured by Lupin Limited in India. It is intended to prevent pregnancy and does not protect against HIV or other sexually transmitted diseases. It is available only by prescription and comes in 28 tablet packs. The product information includes its National Drug Code (NDC) and other identification numbers.*

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