Lopreeza Tablet, Film Coated
Product Images NDC 69238-1609

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Lopreeza (NDC 69238-1609). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Ny 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

Estradiol Structural Formula (Lopreeza Amneal Mfr 1)

Chemical structure of estradiol, the active ingredient in LOPREEZA tablets, shown as a four-ring steroid structure with hydroxyl groups.*

FDA Label Image

Hd Carton Label (Lopreeza Amneal Mfr 10)

Packaging label for Lopreeza 1 mg/0.5 mg film-coated tablets containing estradiol and norethindrone acetate. The label indicates one blister pack with 28 tablets. It features the Amneal logo and states the product is distributed by Amneal Pharmaceuticals NY LLC. The label includes NDC 69238-1610-6 and storage instructions.*

FDA Label Image

Hd Pouch Label (Lopreeza Amneal Mfr 11)

Packaging label for Lopreeza tablets, film-coated, with 1 mg estradiol and 0.5 mg norethindrone acetate per tablet. The label indicates a blister pack containing 28 tablets, manufactured by Amneal Pharmaceuticals NY LLC. The design includes dosage, product name, and manufacturer branding.*

FDA Label Image

Hd Face Label (Lopreeza Amneal Mfr 12)

Lopreeza estradiol/norethindrone acetate tablets 1 mg/0.5 mg oral film-coated tablet blister pack. The label shows a 28-day calendar layout with days of the week and numbered circles for each tablet, indicating the dosing schedule. The labeler is Amneal Pharmaceuticals NY LLC.*

FDA Label Image

Day Label (Lopreeza Amneal Mfr 13)

This image shows a directions sticker for LOPREEZA (estradiol/norethindrone acetate) tablets. It features rows of days of the week in seven-day sequences to apply on the tablet dispenser indicating the day the user starts the medication, with instructions to peel and place the sticker aligning the chosen start day with the dispenser to aid daily pill reminders.*

FDA Label Image

Norethindrone Acetate Structural Formula (Lopreeza Amneal Mfr 2)

Chemical structure of norethindrone acetate, the active ingredient in LOPREEZA tablets containing estradiol and norethindrone acetate.*

FDA Label Image

Figure 1a (Lopreeza Amneal Mfr 3)

A line graph depicting hormone levels (pg/ml) of Estradiol and Estrone over 24 hours. The x-axis represents time in hours, while the y-axis represents hormone concentration in picograms per milliliter. Estrone shows a rise to a peak near 4 hours before gradually declining, whereas Estradiol levels remain relatively steady and low throughout the period.*

FDA Label Image

Figure 1b (Lopreeza Amneal Mfr 4)

A pharmacokinetic curve showing concentration (ng/ml) on the vertical axis versus time (hours) on the horizontal axis. The plot depicts a sharp rise in concentration peaking shortly after administration, followed by a gradual decline over 24 hours.*

FDA Label Image

Figure 2 (Lopreeza Amneal Mfr 5)

A line graph comparing the number of moderate to severe hot flushes per week over 12 weeks among three groups: Placebo, 1 mg Estradiol, and Lopreeza (1 mg estradiol/0.5 mg norethindrone acetate). The graph shows a decline in hot flushes over time for the drug groups compared to placebo, with Lopreeza showing the greatest reduction.*

FDA Label Image

Figure 3 (Lopreeza Amneal Mfr 6)

A line graph comparing the number of moderate to severe hot flushes over a 12-week period between two groups: one taking Lopreeza 0.5 mg/0.1 mg and a placebo group. The vertical axis shows the number of hot flushes, decreasing from about 70 to around 13 in the Lopreeza group and to about 33 in the placebo group. The horizontal axis represents weeks from 0 to 12.*

FDA Label Image

Figure 4 (Lopreeza Amneal Mfr 7)

A line graph comparing the percentage of women over 12 cycles between LOPREEZA and 1 mg estradiol (E2). The x-axis represents the cycle number (1 to 12) and the y-axis shows the percentage of women (40% to 90%). Two lines plot data for LOPREEZA and 1 mg E2, with LOPREEZA showing higher percentages throughout the cycles.*

FDA Label Image

Figure 5 (Lopreeza Amneal Mfr 8)

A line graph comparing percentage of women over six cycles between LOPREEZA 0.5 mg/0.1 mg and placebo groups. The y-axis shows % women from 40 to 100, and the x-axis shows cycles 1 through 6. Data points for both groups increase over time, with placebo consistently higher than LOPREEZA’s values.*

FDA Label Image

Figure 6 (Lopreeza Amneal Mfr 9)

A line graph showing percentage change over lunar months (28-day cycles) comparing LOPREEZA 1 mg/0.5 mg, estradiol 0.5 mg, and placebo groups in EU and US populations. The y-axis represents percentage change, and the x-axis shows lunar months from 0 to 28. Data points include error bars, with LOPREEZA groups showing the greatest positive change over time, estradiol showing moderate increase, and placebo groups showing negative or minimal changes.*

* 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.