Image (Image 01)
Chemical structure of Estradiol, showing its molecular framework with hydroxyl groups and steroid backbone as labeled below the structure.*
Estradiol And Norethindrone Acetate Tablet
Product Images NDC 50090-8004
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Estradiol And Norethindrone Acetate (NDC 50090-8004). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by A-s Medication Solutions, 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
Image (Image 02)
Chemical structure of Norethindrone Acetate, showing its steroid backbone with acetyl functional group.*
Image (Image 03)
A line graph titled 'Mean Baseline-Uncorrected Estradiol and Estrone Serum Concentration-Time Profiles' showing serum concentration (pg/ml) of Estradiol and Estrone over 24 hours after multiple doses of Estradiol and Norethindrone Acetate Tablets 1 mg/0.5 mg (N=24). Estradiol and Estrone concentrations are plotted as separate lines against time (hours).*
Image (Image 04)
A line graph displaying the mean baseline-uncorrected norethindrone serum concentration over time after multiple doses of Estradiol and Norethindrone Acetate tablets (1 mg/0.5 mg). The x-axis represents time in hours (0 to 24), and the y-axis represents serum concentration in ng/ml, showing a peak concentration shortly after dosing followed by a gradual decline over 24 hours.*
Image (Image 05)
A line graph titled 'Mean Weekly Number of Moderate and Severe Hot Flushes in a 12-Week Study' comparing the effects of placebo, 1 mg Estradiol, and Estradiol/Norethindrone Acetate Tablets 1 mg/0.5 mg on the number of moderate to severe hot flushes per week over 12 weeks. The x-axis shows weeks from 0 to 12, and the y-axis shows the number of moderate to severe hot flushes per week from 0 to 80. Each treatment group is represented by a different line style and marker.*
Image (Image 06)
Line graph showing the mean number of moderate to severe hot flushes over 12 weeks. It compares Estradiol/Norethindrone Acetate Tablets 0.5 mg/0.1 mg against placebo, illustrating a decrease in hot flushes for both groups, with a more pronounced reduction for the medication group over time.*
Image (Image 07)
A line graph comparing the percentage of women with no bleeding or spotting over 13 cycles between two groups treated with Estradiol and Norethindrone Acetate Tablets at doses of 1 mg/0.5 mg and 1 mg/0.5 mg (intent to treat population). The graph shows cumulative amenorrhea increase over time, with the 1 mg dose group demonstrating higher percentages across cycles.*
Image (Image 08)
A line graph showing the cumulative amenorrhea over time in patients treated with estradiol and norethindrone acetate tablets 0.5 mg/0.1 mg versus placebo. The X-axis represents treatment cycles 1 through 6, and the Y-axis shows the percentage of women with no bleeding or spotting. The graph compares percentage increases between the active treatment and placebo groups.*
Image (Image 09)
A line graph titled 'Percentage Change in Bone Mineral Density (BMD) ± SEM of the Lumbar Spine (L1-L4)' comparing Estradiol and Norethindrone Acetate Tablets 1 mg/0.5 mg and Estradiol 0.5 mg versus placebo over 26 lunar months (28-day cycles). The graph shows changes in BMD percentage over time for treatment groups in both EU and US populations with separate lines for each group including placebo controls.*
Image (Image 10)
A data table titled 'Relative and Absolute Risk Seen in the Estrogen Plus Progestin Substudy of WHI at an Average of 5.6 Years' showing relative risk and absolute risk per 10,000 women-years for various health events including CHD events, strokes, cancers, fractures, overall mortality, and a global index. The table compares risks between CE/MPA (conjugated estrogens plus medroxyprogesterone acetate) group and placebo, with relative risk values, confidence intervals, and absolute risk counts for both groups.*
Image (Image 11)
Image (Image 12)
A drug facts or safety information panel for estradiol and norethindrone acetate tablets. The text discusses important safety considerations regarding the use of estrogens with or without progestogens, highlighting increased risks of heart attacks, strokes, breast cancer, blood clots, dementia, and uterine cancer with various hormone therapy regimens. It notes the lack of studies on estradiol and norethindrone acetate tablets specifically and advises consultation with healthcare providers.*
Image (Image 13)
Illustration showing a 28-day blister card for oral tablets labeled with days Sunday to Saturday in four weekly rows. The active tablets are yellow and arranged sequentially from left to right to guide daily pill taking. An arrow indicates the direction to take pills, with text instructing to take pills in this direction. The card includes a label area for Estradiol and Norethindrone Acetate dosage and strength.*
Image (Image 14)
An instructional illustration showing a hand holding a weekly oral tablet blister pack for Estradiol and Norethindrone Acetate. The pack is organized by day, Monday through Friday, with rows of circular tablets labeled as active. Arrows and text indicate to take pills from left to right each week.*
Image (Image 15)
Image (Image 18)
A table titled 'All Treatment-Emergent Adverse Reactions Regardless of Relationship Reported at a Frequency of ≥ 5 Percent with Estradiol and Norethindrone Acetate Tablets 1 mg/0.5 mg'. It summarizes adverse reaction frequencies across various body systems from three studies (Endometrial Hyperplasia, Vasomotor Symptoms, Osteoporosis) comparing Estradiol and Norethindrone Acetate tablets to placebo over different study durations.*
Image (Image 19)
Data table titled 'Pharmacokinetic Parameters After Administration' showing mean values and coefficients of variation for Estradiol (E2), Estrone (E1), and Norethindrone (NET) after administration of Estradiol and Norethindrone Acetate tablets at doses of 1 mg/0.5 mg (1 tablet) and 0.5 mg/0.1 mg (2 tablets) to healthy postmenopausal women. Parameters include AUC0-t, Cmax, tmax, and t1/2 with definitions provided below the table.*
Label Image (Lbl500908004)
Label for Estradiol and Norethindrone Acetate tablets, 0.5 mg/0.1 mg strength, oral dosage form. The label indicates the product is distributed by A-S Medication Solutions in Libertyville, Illinois. Packaging instructions note storage below 77 degrees Fahrenheit, protection from light, and blister card packaging with 28 tablets per card. The bottle color is specified as pale yellow.*
* 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.
