Memantine Hydrochloride
Product Images NDC 43353-170

11 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Memantine Hydrochloride (NDC 43353-170). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Principal Display Panel -10 mg Bottle Label (43353 170)

Principal Display Panel -10 mg Bottle Label (43353 170)
Label for Memantine HCl 10 mg tablets, containing 3000 tablets per package. The label indicates the product is repackaged by Aphena Pharma Solutions - Tennessee, LLC, based in Cookeville, TN, and was originally manufactured by Upsher-Smith Laboratories, Minneapolis, MN. The label includes storage instructions and notes it is RX Only.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Chemical Structure (Memantine 01)

Chemical Structure (Memantine 01)
Chemical structure of memantine hydrochloride, showing its adamantane framework with amine and methyl substituents, along with the hydrochloride component.*
FDA Label Image

Figure 1 (Memantine 02)

Figure 1 (Memantine 02)
A line graph comparing mean change from baseline in ADCS-ADL Score over 28 weeks of treatment for Memantine and placebo groups. The x-axis shows weeks of treatment (0 to 28), and the y-axis shows mean change in score with error bars. The Memantine line remains near baseline, indicating less decline, while the placebo line shows greater clinical decline over time.*
FDA Label Image

Figure 2 (Memantine 03)

Figure 2 (Memantine 03)
A cumulative percentage curve graph comparing patients treated with Memantine versus Placebo. The x-axis represents the ADCS-ADL change from baseline, ranging approximately from -25 to 10, and the y-axis shows the cumulative percentage of patients from 0 to 100%. Memantine is represented by an open circle line, and Placebo by a filled square line, with Memantine patients showing higher cumulative percentages at greater positive ADCS-ADL changes.*
FDA Label Image

Figure 3 (Memantine 04)

Figure 3 (Memantine 04)
A line graph showing the mean change from baseline in SIB score over 28 weeks of treatment comparing placebo and Memantine. The graph illustrates clinical improvement and decline over time, with Memantine maintaining closer to baseline scores, while placebo shows a greater decline.*
FDA Label Image

Figure 4 (Memantine 05)

Figure 4 (Memantine 05)
A line chart showing the cumulative percentage of patients plotted against SIB change from baseline. Two groups are compared: Placebo is represented by squares and Memantine by circles. The chart illustrates patient response differences between Placebo and Memantine treatments over the measured change range.*
FDA Label Image

Figure 5 (Memantine 06)

Figure 5 (Memantine 06)
A line graph showing mean change from baseline in ADCS-ADL score over 24 weeks of treatment. It compares the effects of Placebo/Donepezil and Memantine/Donepezil, with data points and error bars indicating variability. The y-axis ranges from clinical improvement to clinical decline.*
FDA Label Image

Figure 6 (Memantine 07)

Figure 6 (Memantine 07)
A cumulative percentage graph showing ADCS-ADL change from baseline for two patient groups: Placebo/Donepezil and Memantine/Donepezil. The vertical axis represents the cumulative percentage of patients, while the horizontal axis shows the ADCS-ADL change from baseline, ranging from positive to negative values. A legend distinguishes the two groups by different markers.*
FDA Label Image

Figure 7 (Memantine 08)

Figure 7 (Memantine 08)
A line graph depicting mean change from baseline in SIB score over 24 weeks of treatment comparing Placebo/Donepezil and Memantine/Donepezil groups. The y-axis shows clinical improvement and decline; the Memantine/Donepezil line trends upward indicating improvement, while the Placebo/Donepezil line trends downward indicating decline.*
FDA Label Image

Figure 8 (Memantine 09)

Figure 8 (Memantine 09)
A line graph showing the cumulative percentage of patients over SIB (Severe Impairment Battery) change from baseline comparing two groups: Placebo/Donepezil and Memantine/Donepezil. The x-axis represents SIB change values, and the y-axis shows cumulative percentage of patients. Memantine/Donepezil group shows a higher cumulative percentage at earlier SIB change values compared to Placebo/Donepezil.*

* 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.