Lopreeza Tablet, Film Coated
Product Images NDC 69238-1252

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Lopreeza (NDC 69238-1252). 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 Chem Structure (Lopreeza Estradiol Norethindrone Acetate Tablets 1)

Chemical structure of the active ingredient estradiol, shown as a molecular diagram with rings and hydroxyl groups consistent with its steroidal structure.*

FDA Label Image

Directions (Lopreeza Estradiol Norethindrone Acetate Tablets 10)

Illustrations showing how to use the Lopreeza dispenser for tablets. Step 1: Turn the inner disc to align the current day with a plastic tab. Step 2: Pull and break off a plastic tab to tip out the first tablet. Step 3: Each day, turn the outer transparent dial one space clockwise as indicated, then tip out the next tablet. A note states the dial can only be turned after the tablet in the opening has been removed.*

FDA Label Image

Ld Dial (Lopreeza Estradiol Norethindrone Acetate Tablets 11)

Round label for Lopreeza tablets containing estradiol/norethindrone acetate, 0.5 mg/0.1 mg strength. The label indicates 28 tablets per package, prescription only. Distributed by Amneal Pharmaceuticals, Glasgow, KY. Includes NDC 69238-1252 and a barcode.*

FDA Label Image

Ld Carton (Lopreeza Estradiol Norethindrone Acetate Tablets 12)

Packaging label for Lopreeza 0.5 mg/0.1 mg tablets containing estradiol and norethindrone acetate. The label shows the product name, active ingredient strengths, and indicates film-coated oral tablets. The labeler is Amneal Pharmaceuticals NY LLC, and the package contains 28 tablets. Storage and handling instructions and manufacturer information (Novo Nordisk A/S, Denmark) are also visible.*

FDA Label Image

Hd Dial (Lopreeza Estradiol Norethindrone Acetate Tablets 13)

Round pharmaceutical label for Lopreeza tablets containing estradiol/norethindrone acetate at a strength of 1 mg/0.5 mg. The label indicates prescription use only with a package count of 28 tablets. Labeler information shows distribution by Amneal Pharmaceuticals, Glasgow, KY. Includes an NDC number and a barcode.*

FDA Label Image

Hd Carton (Lopreeza Estradiol Norethindrone Acetate Tablets 14)

Lopreeza 1 mg/0.5 mg film-coated tablets package label showing the proprietary name and generic names estradiol/norethindrone acetate. It is labeled for oral use with 28 tablets per package. The label indicates manufacture by Novo Nordisk A/S, Denmark and distribution by Amneal Pharmaceuticals NY LLC. Storage information and warnings are provided, along with two barcodes and an NDC number 69238-1251-6.*

FDA Label Image

Noreth Acetate Chem Structure (Lopreeza Estradiol Norethindrone Acetate Tablets 2)

Chemical structure diagram of estradiol, one of the active ingredients in Lopreeza (estradiol/norethindrone acetate). The structure displays the characteristic fused ring system and functional groups typical of estradiol derivatives.*

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Figure 1a (Lopreeza Estradiol Norethindrone Acetate Tablets 3)

A pharmacokinetic graph depicting plasma concentrations (pg/ml) of Estradiol and Estrone over 24 hours. The x-axis represents time in hours, while the y-axis shows concentration levels. Estradiol levels remain relatively low and stable, whereas Estrone levels rise sharply within the first few hours, peak around 4 hours, then gradually decline over 24 hours.*

FDA Label Image

Figure 1b (Lopreeza Estradiol Norethindrone Acetate Tablets 4)

A pharmacokinetic curve showing plasma concentration (ng/ml) on the vertical axis versus time (hours) on the horizontal axis from 0 to 24 hours. The curve rises sharply to a peak near 1 hour, then gradually declines over 24 hours, illustrating drug concentration changes over time after administration.*

FDA Label Image

Figure2 (Lopreeza Estradiol Norethindrone Acetate Tablets 5)

A line graph depicting the number of moderate to severe hot flushes per week over 12 weeks for three groups: Placebo, 1 mg Estradiol, and Lopreeza 1 mg/0.5 mg. The graph shows a decrease in hot flushes for the treatment groups compared to placebo, with Lopreeza showing the most substantial reduction over time.*

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Figure 3 (Lopreeza Estradiol Norethindrone Acetate Tablets 6)

A line graph comparing the number of moderate to severe hot flushes over 12 weeks between Lopreeza 0.5 mg/0.1 mg and placebo groups. The y-axis shows the number of hot flushes, decreasing over time, and the x-axis represents weeks from 0 to 12. Lopreeza shows a greater reduction compared to placebo.*

FDA Label Image

Figure 4 (Lopreeza Estradiol Norethindrone Acetate Tablets 7)

A line graph comparing % minimum values over 12 cycles between 1 mg E2 and Lopreeza groups. The x-axis represents the cycle number (1 to 12), and the y-axis shows % minimum values from 40% to 100%. Two lines track changes across cycles for 1 mg E2 and Lopreeza, with Lopreeza generally showing lower percentage values than 1 mg E2 throughout the cycles.*

FDA Label Image

Figure 5 (Lopreeza Estradiol Norethindrone Acetate Tablets 8)

A line graph comparing the percentage of women across six cycles between Lopreeza 0.5 mg/0.1 mg and placebo groups. The x-axis represents cycles 1 to 6, and the y-axis shows the percent of women ranging from 40 to 100%. Two lines depict data trends: a solid line for Lopreeza and a dashed line for placebo.*

FDA Label Image

Figure6 (Lopreeza Estradiol Norethindrone Acetate Tablets 9)

A line graph showing percentage change over lunar months (28-day cycles) comparing treatment groups: Lopreeza 1 mg/0.5 mg in EU and US, Estradiol 0.5 mg in US, and placebo groups in EU and US. The graph includes data points with error bars for each group across a time span of 0 to 26 lunar months.*

* 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.