Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium Kit
Product Images NDC 0781-4075

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium (NDC 0781-4075). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sandoz 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

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Round, pink tablet with an imprint of a hexagon containing a capital letter 'Z' and a plus sign on one side and a plain surface on the other side. The scale at the sides indicates the tablet is about 7 mm in diameter. This image is associated with Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium oral medication, a kit product by Sandoz Inc.*

FDA Label Image

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Image showing two views of a round, beige tablet with the imprint 'M+' inside a hexagon on one side. The other side is plain and without markings. The scale below indicates the tablet’s diameter is approximately 7 mm. This tablet is part of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium, a prescription drug kit by Sandoz Inc.*

FDA Label Image

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A forest plot chart titled 'Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives' displaying effect estimates from several studies comparing breast cancer risk in ever users versus never users and current users versus never users of combined oral contraceptives. The horizontal axis shows effect estimates ranging from -1.50 to 2.00, with confidence intervals illustrated by horizontal lines for each study.*

FDA Label Image

Fig 1 (Image 01)

A forest plot chart illustrating hazard ratios, rate ratios, and odds ratios with confidence intervals from various studies, including prospective cohort, retrospective cohort, case-control, and non-fatal idiopathic cases only studies. The x-axis ranges from 0.1 to 10, with a vertical line at 1 indicating the null effect.*

FDA Label Image

Fig 2 (Image 02)

A bar chart illustrating the number of women with a blood clot per 10,000 women years (WY) categorized by non-pregnant non-COC users, COC users, pregnant women, and postpartum women (12 weeks only). The chart shows increasing blood clot risk from non-pregnant non-COC users to postpartum women, with specific ranges noted for each group.*

FDA Label Image

Structures (Image 03)

Chemical structures of three active ingredients: Drospirenone, Ethinyl estradiol, and Levomefolate Calcium. Each structure is detailed and labeled with its respective compound name, showing molecular arrangements relevant to the combined human prescription drug product by Sandoz Inc.*

FDA Label Image

Fig 3 (Image 04)

A line graph comparing two groups over a 24-week period: YAZ + levomefolate calcium and YAZ alone. The graph plots a measured variable on the vertical axis, ranging from 0 to 100, against time in weeks on the horizontal axis, with data points at pre-treatment and intervals up to 24 weeks. Error bars are shown for each point, indicating variability within each group.*

FDA Label Image

Fig 4 (Image 05)

A line chart comparing two groups over a 24-week period: 'YAZ + levomefolate calcium (N=122)' and 'YAZ (N=44)'. The vertical axis measures a numeric value ranging from 0 to 2000, while the horizontal axis represents time in weeks, from pre-treatment to 24 weeks. Error bars indicate variability for each data point.*

FDA Label Image

Fig 5 (Image 06)

A line graph showing plasma folate concentration over time in weeks for subjects treated with Yasmin plus levomefolate calcium (N=75). The timeline is divided into pre-treatment, treatment, and elimination phases, with concentrations peaking around week 22 and then declining during the elimination phase.*

FDA Label Image

Fig 6 (Image 07)

A line graph showing changes over time (weeks) for a treatment group labeled Yasmin plus levomefolate calcium (N=75). The x-axis represents time in weeks from pre-treatment through a treatment phase to an elimination phase, while the y-axis measures a variable increasing to a peak and then decreasing, with error bars indicating variability at each time point. A baseline is marked at week 24, separating the treatment and elimination phases.*

FDA Label Image

Birth Control Chart (Image 08)

An informational diagram illustrating contraceptive methods arranged by effectiveness, with fewer pregnancies per 100 women per year at the top and more pregnancies at the bottom. Methods listed from most to least effective include implants, injections, intrauterine devices, sterilization; birth control pills, skin patch, vaginal ring with hormones; condoms and diaphragm; no sex during fertile days, spermicide, withdrawal; and no birth control at the lowest effectiveness level.*

FDA Label Image

Blister (Image 09)

Blister packaging labeled for Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium tablets, showing 28 circular tablet slots arranged in four rows. The header space instructs to place a day label. Dosage strengths visible are 3 mg, 0.02 mg, and 0.451 mg. The labeler is Sandoz Inc.*

FDA Label Image

Vte Chart (Image 10)

A horizontal bar chart depicting the number of women with a blood clot per 10,000 women years (WY) among four groups: Non-Pregnant Non-COC users (range 1-5), COC users (range 3-9), Pregnant women (range 5-20), and Postpartum women within 12 weeks (range 40-65). The x-axis represents the number of women with a blood clot, ranging from 0 to 70.*

FDA Label Image

Carton 3s (Image 11)

Packaging label for Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablets and Levomefolate Calcium Tablets kit, containing 3 mg/0.02 mg/0.451 mg and 0.451 mg doses. The kit includes 3 units of 3 x 28 oral tablets. The label shows the product is Rx only, distributed by Sandoz Inc, a Novartis company, and includes NDC 0781-4075-15.*

* 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.