Rivastigmine Transdermal System Patch, Extended Release
Product Images NDC 51991-898

20 FDA label images from Breckenridge Pharmaceutical, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Rivastigmine Transdermal System (NDC 51991-898). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Breckenridge Pharmaceutical, Inc., 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

Chemical Structure (Rivastigmine 01)

Chemical Structure (Rivastigmine 01)
Chemical structure of rivastigmine, the active ingredient in Rivastigmine Transdermal System. The diagram shows the molecular arrangement including a carbamate group connected to a substituted phenyl ring and amine groups.*
FDA Label Image

Figure 1 (Rivastigmine 02)

Figure 1 (Rivastigmine 02)
An illustration showing the layered structure of the Rivastigmine Transdermal System patch. The diagram labels four distinct layers and highlights two dimples on the patch as indicated by arrows. The patch design appears cross-sectional, emphasizing its composition and texture features.*
FDA Label Image

Figure 2 (Rivastigmine 03)

Figure 2 (Rivastigmine 03)
A line graph showing Rivastigmine plasma concentration (ng/mL) over time (hours) for three dosages of Rivastigmine Transdermal System patches: 13.3 mg/24h, 9.5 mg/24h, and 4.6 mg/24h. The graph compares mean drug levels with error bars across a 24-hour period for each dose group.*
FDA Label Image

Figure 3 (Rivastigmine 04)

Figure 3 (Rivastigmine 04)
A line graph showing least square mean change (+/- SEM) from baseline ADAS-cog ratings over 24 weeks of treatment. The graph compares four groups: Rivastigmine Transdermal System at 17.4 mg/24 hours, 9.5 mg/24 hours, oral capsules 6 mg BID, and placebo. The y-axis represents clinical improvement (negative change) to clinical decline (positive change), while the x-axis represents weeks during treatment from 0 to 24.*
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Figure 4 (Rivastigmine 05)

Figure 4 (Rivastigmine 05)
A bar chart displaying the distribution of ADCS-CGIC ratings among patients across four treatment groups: 17.4 mg/24 hours, 9.5 mg/24 hours of Rivastigmine Transdermal System, capsules 6 mg BID, and placebo. The ratings range from Markedly Improved to Markedly Worse, with the highest percentage in the No Change category for all groups.*
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Figure 5 (Rivastigmine 06)

Figure 5 (Rivastigmine 06)
A line graph showing ADCS-IADL change from baseline over 48 weeks of treatment comparing Rivastigmine Transdermal System at two strengths: 13.3 mg/24hr and 9.5 mg/24hr. The vertical axis measures clinical improvement and decline, while the horizontal axis shows weeks of treatment. Data points with error bars illustrate the trend of clinical decline over time for both strengths, with the 9.5 mg/24hr group showing a steeper decline.*
FDA Label Image

Figure 6 (Rivastigmine 07)

Figure 6 (Rivastigmine 07)
A line graph depicting the change from baseline in ADAS-Cog scores over 48 weeks of treatment with Rivastigmine Transdermal System at doses of 13.3 mg/24hr and 9.5 mg/24hr. The x-axis represents weeks of treatment, and the y-axis represents the change in scores, with clinical improvement indicated upwards and clinical decline downwards. Two lines show score trends with error bars for each dose group.*
FDA Label Image

Figure 7 (Rivastigmine 08)

Figure 7 (Rivastigmine 08)
A line graph comparing the efficacy of Rivastigmine Transdermal System 15 cm² and 5 cm² patches over 24 weeks of treatment. The vertical axis shows LS mean change plus/minus standard errors, indicating clinical improvement and decline. The horizontal axis indicates weeks of treatment. Data points include statistical values and significance levels, showing better outcomes for the 15 cm² patch.*
FDA Label Image

Figure 8 (Rivastigmine 09)

Figure 8 (Rivastigmine 09)
A line graph showing least squares mean changes over 24 weeks of treatment comparing Rivastigmine Transdermal System 15 cm² and 5 cm² patches. The y-axis represents LS mean change with standard error, indicating clinical improvement at the top and clinical decline at the bottom. The x-axis shows weeks of treatment (0, 8, 16, 24). Data points with error bars demonstrate average changes, with p-values and confidence intervals noted, highlighting statistical significance at weeks 16 and 24 for the larger patch size.*
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Figure A (Rivastigmine 10)

Figure A (Rivastigmine 10)
An instructional diagram illustrating the Rivastigmine Transdermal System patch components. It shows a labeled pouch for the patch with the Breckenridge Pharmaceutical logo, a patch with protective liners and the Rivastigmine label, and a detailed view of the patch featuring adhesive with medicine, protective liners, and an outside backing layer.*
FDA Label Image

Figure B (Rivastigmine 11)

Figure B (Rivastigmine 11)
Illustration showing possible application sites for the Rivastigmine Transdermal System patch on the body. It depicts four body areas with shaded regions indicating where the patch can be applied: left or right upper arm (side view), left or right side of the chest (front and back views), left or right upper back, and left or right lower back.*
FDA Label Image

Figure C (Rivastigmine 12)

Figure C (Rivastigmine 12)
An instructional illustration showing a hand holding a rivastigmine transdermal system patch package. The package is labeled "Rivastigmine Transdermal System" with instructions "For Transdermal Use Only" and "Rx Only." A pair of scissors is depicted next to the package, suggesting the patch system is to be opened by cutting the package.*
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Figure D (Rivastigmine 13)

Figure D (Rivastigmine 13)
An instructional illustration showing hands peeling protective liners off a rivastigmine transdermal system patch, revealing the sticky surface of the patch for application.*
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Figure E (Rivastigmine 14)

Figure E (Rivastigmine 14)
Instructional illustration showing the application of the Rivastigmine Transdermal System patch to the upper back of a person. A hand is seen placing the patch on the skin while another hand presses down on the patch to secure it.*
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Figure F (Rivastigmine 15)

Figure F (Rivastigmine 15)
An instructional illustration showing a human upper back and a hand placing a transdermal patch on the skin. This diagram likely demonstrates proper application of a transdermal system medication patch on the back of the shoulder area.*
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Figure G (Rivastigmine 16)

Figure G (Rivastigmine 16)
Illustration showing the application of a Rivastigmine transdermal patch to the upper chest area. One hand is peeling the patch from its backing while the other hand is positioned on the chest, demonstrating proper placement for transdermal delivery.*
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Figure H (Rivastigmine 17)

Figure H (Rivastigmine 17)
Illustration showing how to properly dispose of a Rivastigmine Transdermal System extended release patch. It depicts folding the sticky sides of the patch together, placing the folded patch into an empty pouch, and then discarding the pouch in the trash while keeping it away from children and pets.*
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Principal Display Panel (4.6 mg Patch Pouch Carton)

Principal Display Panel (4.6 mg Patch Pouch Carton)
Rivastigmine Transdermal System 4.6 mg/24 hours is an extended-release patch for transdermal use. The packaging contains 30 systems and is labeled for prescription use only by Breckenridge Pharmaceutical, Inc. Instructions for discarding and storage conditions are provided on the box, along with warnings to keep out of reach of children and apply immediately after removal from the pouch.*
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Principal Display Panel (9.5 mg Patch Pouch Carton)

Principal Display Panel (9.5 mg Patch Pouch Carton)
The packaging label for Rivastigmine Transdermal System, each system delivering 9.5 mg/24 hours in an extended-release transdermal patch form. The carton contains 30 systems and is labeled for transdermal use only, distributed by Breckenridge Pharmaceutical, Inc. Instructions for patch disposal and storage at 25°C are included, along with the manufacturer information (APEXPHARMA, Inc.). The label includes the NDC 51991-898-30 and states Rx Only.*
FDA Label Image

Principal Display Panel (13.3 mg Patch Pouch Carton)

Principal Display Panel (13.3 mg Patch Pouch Carton)
Packaging label for Rivastigmine Transdermal System delivering 13.3 mg/24 hours, an extended-release patch for transdermal use. The label indicates a package of 30 systems, distributed by Breckenridge Pharmaceutical, Inc. Instructions for discarding used patches and storage conditions are provided. The product is Rx only and manufactured by Apotex Corp.*

* 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.