Dolishale Tablet
Product Images NDC 50742-659

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Dolishale (NDC 50742-659). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ingenus Pharmaceuticals, Llc, 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

Image (Image 01)

Chemical structure diagram showing levonorgestrel (C21H28O2, molecular weight 312.45) and ethinyl estradiol (C20H24O2, molecular weight 296.40), the active ingredients of Dolishale tablets.*

FDA Label Image

Image (Image 02)

Pharmacokinetic line graphs depicting Levonorgestrel and Ethinyl Estradiol plasma concentrations over time in hours. The top graph shows Levonorgestrel plasma concentration (ng/mL) for Days 1, 14, and 28, with error bars representing standard deviation. The bottom graph shows Ethinyl Estradiol plasma concentration (pg/mL) over the same days and time points, also with error bars.*

FDA Label Image

Image (Image 03)

A bar chart depicting the percentage of subjects experiencing amenorrhea across 13 pill packs. The x-axis represents sequential pill packs numbered 1-13, and the y-axis shows the percentage of subjects, reaching up to 100%. The chart shows an increasing trend in amenorrhea incidence as the pill packs progress. Below the chart, a note states 779 subjects had complete data for 13 pill packs, with subjects beginning pack 1 on the first day of menses.*

FDA Label Image

Image (Image 04)

A vertical bar chart comparing four groups—ever-users (nonsmokers), controls (nonsmokers), ever-users (smokers), and controls (smokers)—across four age ranges (15-24, 25-34, 35-44, 45+). The chart shows counts or measurements for each group and age category, with the tallest bar in the 45+ ever-users (smokers) group. The source is adapted from P.M. Layde and V. Beral, Lancet, 1981.*

FDA Label Image

Image (Image 05)

A bar chart titled 'Percentage of Subjects Reporting Bleeding or Spotting Only per Pill Pack' displays the percentage of subjects experiencing bleeding or spotting over multiple pill packs. The x-axis represents pill pack numbers from less than 2 to 13, and the y-axis shows percentages from 0 to 100. Bars are segmented into bleeding (solid fill) and spotting only (pattern fill), with an annotation explaining definitions and sample sizes per pill pack.*

FDA Label Image

Image (Image 06)

A bar chart titled 'Percentage of Subjects Reporting Greater Than or Equal to 4 or 7 Days of Bleeding and/or Spotting per Pill Pack (Study 313-NA).' The x-axis represents sequential pill packs numbered from less than 2 to 13, and the y-axis shows the percentage of subjects from 0 to 100%. Each pill pack bar is divided into two parts: the lower white section representing the percentage with 7 or more days and the upper black section representing 4 or more days. The number of subjects with 28 days of data is listed below each pill pack.*

FDA Label Image

Image (Image 07)

FDA Label Image

Image (Image 08)

An instructional diagram showing a hand placing a day label sticker over a birth control tablet blister pack labeled Dolishale. The tablet pack contains 28 green active tablets arranged in four rows. The diagram provides directions for starting the pack on the correct day of the week and taking pills from left to right.*

FDA Label Image

Image (Image 09)

A data table showing the annual number of birth-related or method-related deaths associated with fertility control per 100,000 nonsterile women. The table categorizes deaths by fertility-control method and age groups ranging from 15 to 44 years. Methods include no fertility-control, oral contraceptives (non-smoker and smoker), IUD, condom, diaphragm/spermicide, and periodic abstinence with associated death rates varying by method and age.*

FDA Label Image

Image (Image 10)

A bar chart titled 'Percentage of Subjects Reporting Bleeding or Spotting Only per Pill Pack' shows the percentage of subjects reporting bleeding or spotting over various pill packs. The chart differentiates bleeding (solid bars) and spotting only (checkered bars) with percentages on the vertical axis and pill pack numbers on the horizontal axis. Additional notes below explain the subject count per pill pack and that bleeding required sanitary protection, whereas spotting did not.*

FDA Label Image

Image (Image 11)

A bar chart showing the percentage of subjects reporting 4 or more days and 7 or more days of bleeding and/or spotting per pill pack in Study 313-NA. The x-axis lists pill packs from 2 to 13, with the sample size (N) below each. The y-axis shows the percentage of subjects from 0 to 100%. Dark bars represent 4 or more days, and light bars represent 7 or more days of bleeding/spotting.*

FDA Label Image

Image (Image 12)

An instructional illustration showing a hand placing a day label sticker starting with the first day of the period onto a blister pack of Dolishale tablets. The pack contains 28 green active tablets arranged in a two-row grid with directions to start taking pills from left to right. The diagram includes arrows and labels to guide pill usage.*

FDA Label Image

Image (Image 13)

FDA Label Image

1-cycle Carton (Image 14)

Dolishale 90 mcg/20 mcg tablets, a human prescription drug containing Levonorgestrel and Ethinyl Estradiol, USP in oral tablet form. The carton is labeled for 1 blister card of 28 tablets. It is manufactured by Ingenus Pharmaceuticals, LLC. The label includes usage notes, dosage strength, NDC 50742-659-28, and a blue flower graphic.*

FDA Label Image

3-cycle Carton (Image 15)

Packaging label for Dolishale, Levonorgestrel and Ethinyl Estradiol Tablets USP, 90 mcg/20 mcg, oral tablet by Ingenus Pharmaceuticals, LLC. The label indicates a package containing 3 blister cards of 28 tablets each with product warnings, dosing instructions, storage information, and barcodes.*

* 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.