Estradiol Film, Extended Release
Product Images NDC 68968-3437

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Estradiol (NDC 68968-3437). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Noven Therapeutics, 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.

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Chemical Structure (Estradiol Figure 1)

Chemical structure diagram of estradiol, showing its steroid nucleus with hydroxyl groups at specified positions, consistent with the active ingredient in the Estradiol transdermal extended release film product by Noven Therapeutics, LLC.*

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Figure D (Estradiol Figure 10)

An instructional line drawing showing two hands peeling apart a circular adhesive film, demonstrating how to separate the layers of an estradiol transdermal extended-release film patch before application.*

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Figure E, F (Estradiol Figure 11)

Two black-and-white line drawings show a person applying a transdermal film to the lower abdomen area just above the underwear line. The illustrations demonstrate proper placement of the Estradiol extended-release transdermal film patch on the skin.*

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Figure G (Estradiol Figure 12)

An instructional line drawing showing hands applying a transdermal film patch to the lower abdomen area, illustrating the proper placement technique for a transdermal drug delivery system.*

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0.025 mg Pouch Label (Estradiol Figure 13)

Packaging label for Estradiol Transdermal System film, extended release, delivering 0.025 mg/day. The label indicates Rx only, twice-weekly application, and contains 8 systems. Distributed by Grove Pharmaceuticals, Miami, Florida. The label includes dosage, storage instructions, a barcode, and a reminder application schedule checklist.*

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0.025 mg 8-count Carton Label (Estradiol Figure 14)

Estradiol Transdermal System 0.0375 mg/day extended-release film label. The rectangular label includes the brand and generic name, strength, dosage form, and directions such as twice-weekly application and a schedule checklist for patch days. It notes the package contains 8 systems, Rx only, and is distributed by Grove Pharmaceuticals, Miami, Florida.*

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0.0375 mg Pouch Label (Estradiol Figure 15)

Estradiol Transdermal System 0.05 mg/day extended release film packaging label. The label states it delivers 0.05 mg/day of estradiol and contains 8 systems for twice-weekly application. The product is Rx only and is distributed by Grove Pharmaceuticals, Miami, Florida. The label includes instructions for a flexible application schedule and child-resistant packaging warnings. Barcodes and lot/expiration placeholders are visible.*

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0.0375 mg 8-count Carton Label (Estradiol Figure 16)

Packaging label for Estradiol Transdermal System 0.075 mg/day film, extended release. The label shows the brand name Estradiol with a dosage strength of 0.075 mg/day, for transdermal delivery. It states "Twice-Weekly Rx Only Includes 8 Systems." The labeler is Grove Pharmaceuticals, Miami, Florida, with NDC 68968-3475-8. Additional information includes application schedule directions and storage instructions, and the package contains 8 systems.*

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0.050 mg Pouch Label (Estradiol Figure 17)

Packaging label for Estradiol Transdermal System delivering 0.1 mg/day. The label states it includes 8 systems for twice-weekly application and is distributed by Grove Pharmaceuticals, Miami, Florida. The packaging provides instructions for application schedule options and storage conditions, with emphasis on keeping the product out of reach of children and in original packaging at 20°C to 25°C (68°F to 77°F).*

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Layers (Estradiol Figure 2)

An instructional diagram illustrating the three layers of an Estradiol transdermal extended release film. The layers are labeled as (1) Backing, (2) Adhesive containing Estradiol, and (3) Protective liner.*

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Figure1 (Estradiol Figure 3)

A line graph depicting serum concentration (pg/mL) of estradiol over time (days) following administration of three doses: 0.1 mg/day, 0.05 mg/day, and 0.025 mg/day. The graph shows the concentration peaking within approximately 1 to 1.5 days and gradually declining over 5 days for each dose level.*

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Figure2 (Estradiol Figure 4)

A bar chart comparing mean (SD) reduction from baseline at weeks 4, 8, and 12 between Vivelle 0.0375 mg/day and placebo. The x-axis shows time points (Week 4, Week 8, Week 12) with associated sample sizes; the y-axis shows mean reduction values. Black bars represent Vivelle 0.0375 mg/day with greater reductions, and white bars represent placebo with smaller reductions. Statistically significant differences between Vivelle and placebo are indicated at each time point.*

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Figure3 (Estradiol Figure 5)

A line graph showing percent change from baseline over treatment duration at weeks 26, 52, 78, and 104. The graph compares different dosing groups of Vivelle estradiol transdermal film (0.1 mg/day, 0.05 mg/day, 0.0375 mg/day, 0.025 mg/day) and a placebo group, with each dose represented by distinct line styles and markers as detailed in the legend below the graph.*

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Figure4 (Estradiol Figure 6)

A line graph showing the percent change from baseline over treatment duration (weeks 26 to 104) for Estradiol transdermal film at different doses (0.025, 0.0375, 0.05, 0.1 mg/day) compared to placebo. The graph depicts improved outcomes with increasing dosage, with significant differences marked between treatment groups and placebo at various time points.*

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Figure A (Estradiol Figure 7)

An instructional illustration showing the spray packaging components for Estradiol transdermal system by Noven Therapeutics, LLC. The image includes a carton, a calendar-style dispenser, and a pouch containing the extended release film patch labeled Estradiol.*

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Figure B (Estradiol Figure 8)

An instructional illustration showing a hand holding a pen poised over a form or diary titled 'Estradiol Transdermal System.' The form appears designed for recording medication use or patient information related to the estradiol transdermal system by Noven Therapeutics, LLC.*

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Figure C (Estradiol Figure 9)

An instructional line drawing showing hands opening a foil packet of Estradiol transdermal film, extended release. The image highlights peeling the package open to remove the film. The product is from Noven Therapeutics, LLC, available in various daily doses.*

* 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.