Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium Kit
Product Images NDC 0781-4103

12 FDA label images from Sandoz Inc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium (NDC 0781-4103). 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

Chem Structure (Image 01)

Chem Structure (Image 01)
Chemical structure diagrams of the active ingredients Drospirenone, Ethinyl estradiol, and Levomefolate Calcium, as labeled and depicted in the image.*
FDA Label Image

Fig 1 (Image 02)

Fig 1 (Image 02)
Kit packaging for Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium by Sandoz Inc. The label identifies it as a human prescription drug kit with NDC 0781-4103. The packaging features the brand and generic names prominently on a white background with teal and gray accent colors, including product information and usage instructions.*
FDA Label Image

Fig 2 (Image 03)

Fig 2 (Image 03)
A bar chart comparing the number of women with a blood clot per 10,000 women years (WY) across four groups: Non-Pregnant Non-COC users (ranges from 1 to 5), COC users (ranges from 3 to 9), Pregnancy (ranges from 5 to 20), and Postpartum (12 weeks only) with the highest range from 40 to 65. The chart visualizes relative blood clot risk in these populations.*
FDA Label Image

Chart (Image 04)

Chart (Image 04)
An illustration diagram showing a vertical scale of pregnancy rates ranging from fewer than 1 to 85 or more pregnancies per 100 women in one year. The diagram categorizes contraceptive methods by effectiveness. At the top, highly effective methods include implants, injections, intrauterine devices, and sterilization. Following are birth control pills, skin patch, and vaginal ring with hormones. Condoms and diaphragm are in the middle. Methods with higher pregnancy rates include abstinence during fertile days, spermicide, and withdrawal. At the bottom, no birth control is listed as leading to the highest pregnancy rate.*
FDA Label Image

Blister (Image 05)

Blister (Image 05)
Kit packaging label for Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium tablets. The image shows a blister pack layout with multiple round tablets arranged in rows, indicating combination tablets with dosages of 3 mg, 0.03 mg, and 0.451 mg along with additional levomefolate calcium tablets. The label includes a place to add a day-of-week label and a starting point indicator. The product is from Sandoz Inc.*
FDA Label Image

Graph (Image 06)

Graph (Image 06)
A bar chart showing the number of women with a blood clot per 10,000 women years (WY) across four groups: Non-Pregnant Non-COC users (range 1 to 5), COC users (range 3 to 9), Pregnancy (range 5 to 20, pregnancy duration based on a model of nine months), and Postpartum (12 weeks only, range 40 to 65). The x-axis represents the number of women with blood clots per 10,000 WY, ranging from 0 to 70.*
FDA Label Image

Fig 3 (Image 07)

Fig 3 (Image 07)
Line graph comparing plasma folate levels (nmol/L) over 24 weeks between two groups: one treated with YAZ plus levomefolate calcium and another with YAZ alone. The y-axis represents plasma folate concentration, and the x-axis represents time in weeks from pre-treatment to 24 weeks. The graph shows higher plasma folate levels in the YAZ plus levomefolate calcium group consistently across the treatment period.*
FDA Label Image

Fig 4 (Image 08)

Fig 4 (Image 08)
A line graph depicting RBC folate levels (nmol/L) over 24 weeks, comparing two groups: YAZ plus levomefolate calcium and YAZ alone. The x-axis represents time in weeks from pre-treatment to 24 weeks, and the y-axis shows RBC folate concentrations ranging from 0 to 2000 nmol/L. The YAZ plus levomefolate calcium group shows an increasing trend in RBC folate, while the YAZ alone group remains relatively stable.*
FDA Label Image

Fig 6 (Image 09)

Fig 6 (Image 09)
A line graph depicting RBC folates levels (nmol/L) over 44 weeks in subjects taking Yasmin plus levomefolate calcium (N=75). The x-axis shows time in weeks from pre-treatment through treatment and elimination phases, while the y-axis measures RBC folate concentrations. The graph shows a rise in folate levels during treatment, peaking around week 22, followed by a decline in the elimination phase.*
FDA Label Image

Carton 3s (Image 10)

Carton 3s (Image 10)
Packaging label for Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablets and Levomefolate Calcium Tablets by Sandoz Inc. The kit contains 3 units of 28 oral tablets each, with active ingredient strengths of 3 mg/0.03 mg/0.451 mg and 0.451 mg. The label indicates this is a prescription-only oral contraceptive product.*
FDA Label Image

Fig 5 (Image 11)

Fig 5 (Image 11)
The line graph shows plasma folate levels (nmol/L) over time (weeks) in 75 subjects treated with Yasmin plus levomefolate calcium. It displays a treatment phase with increasing folate levels, peaking around week 22, followed by an elimination phase with decreasing levels toward baseline. Error bars indicate variability at each time point.*
FDA Label Image

Image 12

Image 12
A forest plot chart titled 'Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives' that compares effect estimates of breast cancer risk between ever vs. never use and current vs. never use of combined oral contraceptives (COC). It includes study names, years, and various effect measures (OR, RR, HR) with confidence intervals plotted along an effect estimate axis from -1.50 to 2.00.*

* 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.