Memantine And Donepezil Hydrochlorides Capsule, Extended Release
Product Images NDC 62559-207

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Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Memantine And Donepezil Hydrochlorides (NDC 62559-207). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ani Pharmaceuticals, 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

21-10label (21 10label)

21-10label (21 10label)
Text panel for Memantine and Donepezil Hydrochlorides Extended-Release Capsules 21 mg/10 mg by ANI Pharmaceuticals, Inc. Includes dosage instructions, storage conditions (20° to 25°C), moisture protection, dispensing guidance, and safety warning to keep out of reach of children. Also shows the NDC number 62559-207-30, distributor address, barcode, and placeholders for serial number, lot, and expiration date.*
FDA Label Image

Donepezil-structure (Donepezil Structure)

Donepezil-structure (Donepezil Structure)
Chemical structure diagram of MEMANTINE AND DONEPEZIL HYDROCHLORIDES, showing the molecular arrangement with aromatic rings, methoxy groups, and hydrochloride indicated.*
FDA Label Image

Figure-1 (Figure 1)

Figure-1 (Figure 1)
Line graph depicting the mean change from baseline in SIB (Severe Impairment Battery) score over 24 weeks of treatment. The graph compares two groups: Memantine HCl ER 28 mg/AChEI and Placebo/AChEI. The x-axis represents weeks of treatment, and the y-axis shows mean change in SIB score, with annotations for clinical improvement and decline. Error bars indicate standard error of the mean (SEM).*
FDA Label Image

Figure-2 (Figure 2)

Figure-2 (Figure 2)
A cumulative percentage graph comparing patients' SIB change from baseline between Memantine HCl ER 28 mg/AChEI and placebo/AChEI groups. The x-axis represents the SIB change from baseline, while the y-axis shows the cumulative percentage of patients. Two curves illustrate patient response distributions for the two treatments.*
FDA Label Image

Figure-3 (Figure 3)

Figure-3 (Figure 3)
A line graph depicting mean CIBIC-Plus scores with standard error bars over 24 weeks of treatment. It compares Memantine HCl ER 28 mg/AChEI (black diamonds) against Placebo/AChEI (white squares), showing trends in clinical improvement and decline marked by a horizontal line at score 4.0.*
FDA Label Image

Figure-4 (Figure 4)

Figure-4 (Figure 4)
A bar chart comparing CIBIC-Plus ratings for patients taking Memantine HCl ER 28 mg/AChEI versus Placebo/AChEI. The x-axis shows rating categories from marked improvement to marked worsening, while the y-axis represents the percentage of patients. Black bars indicate Memantine HCl ER 28 mg/AChEI, white bars indicate Placebo/AChEI.*
FDA Label Image

Figure-5 (Figure 5)

Figure-5 (Figure 5)
Line graph showing SIB (Severe Impairment Battery) change from baseline over 6 months of drug treatment comparing donepezil hydrochloride 10 mg/day with placebo. The y-axis represents mean change from baseline with standard error, ranging from clinical decline to clinical improvement. The x-axis indicates time in months (0, 3, 6). Donepezil shows clinical improvement, while placebo trends toward clinical decline.*
FDA Label Image

Figure-6 (Figure 6)

Figure-6 (Figure 6)
A cumulative percentage curve comparing patients taking donepezil hydrochloride 10 mg/day versus placebo based on SIB change from baseline. The x-axis shows SIB change from baseline with negative values indicating improvement, and the y-axis shows the cumulative percentage of patients, illustrating a greater shift toward improvement in the donepezil group compared to placebo.*
FDA Label Image

Figure-7 (Figure 7)

Figure-7 (Figure 7)
A line graph showing the ADCS-ADL change from baseline (mean ± SE) over 6 months of drug treatment comparing donepezil hydrochloride 10 mg/day and placebo. The vertical axis shows clinical improvement and decline, while the horizontal axis shows months of treatment (0, 3, and 6 months). Donepezil hydrochloride shows less clinical decline compared to placebo over time.*
FDA Label Image

Figure-8 (Figure 8)

Figure-8 (Figure 8)
A cumulative percentage of patients graph comparing donepezil hydrochloride 10 mg/day with placebo. The x-axis shows ADCS-ADL change from baseline ranging from -20 to 20, and the y-axis shows cumulative percentage of patients from 0 to 100%. Data points for donepezil hydrochloride are marked with filled circles, and placebo with open squares.*
FDA Label Image

Memantine-structure (Memantine Structure)

Memantine-structure (Memantine Structure)
Chemical structure diagram showing the molecular structure of memantine with labels indicating NH2 and HCl groups, methyl groups (CH3), and a bicyclic cage framework.*

* 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.