Risedronate Sodium Tablet, Film Coated
Product Images NDC 65862-870

9 FDA label images from Aurobindo Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Risedronate Sodium (NDC 65862-870). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure 1 (Risedronate Fig1)

Figure 1 (Risedronate Fig1)
A bar chart titled 'Nonvertebral Osteoporosis-Related Fractures Cumulative Incidence Over 3 Years Combined VERT MN and VERT NA'. It compares the percentage of patients with fractures at different sites (All, Wrist, Humerus, Hip, Pelvis, Leg, Clavicle) between Placebo and Risedronate Sodium 5 mg groups.*
FDA Label Image

Figure 2 (Risedronate Fig2)

Figure 2 (Risedronate Fig2)
A bar graph titled "Figure 2 Change in BMD from Baseline 2-Year Prevention Study" showing mean percentage change in bone mineral density (BMD) at three anatomical sites: Lumbar Spine, Femoral Neck, and Femoral Trochanter. The graph compares placebo and Risedronate Sodium 5 mg groups, indicating positive BMD changes for Risedronate Sodium and negative changes for placebo at each site.*
FDA Label Image

Fig3 (Risedronate Fig3)

Fig3 (Risedronate Fig3)
A bar graph titled 'Change in BMD from Baseline Patients Recently Initiating Glucocorticoid Therapy' comparing percent change in bone mineral density (BMD) between placebo and Risedronate Sodium 5 mg groups at three anatomical sites: Lumbar Spine, Femoral Neck, and Femoral Trochanter. Bars for Risedronate Sodium show positive BMD changes, while placebo bars show negative changes, with sample sizes indicated above each bar.*
FDA Label Image

Fig4 (Risedronate Fig4)

Fig4 (Risedronate Fig4)
A bar chart titled 'Change in BMD from Baseline Patients on Long-Term Glucocorticoid Therapy' comparing mean percent change in bone mineral density (BMD) with standard error in lumbar spine, femoral neck, and femoral trochanter regions. Data compares placebo (white bars) and Risedronate Sodium 5 mg (black bars) groups with sample sizes noted for each region.*
FDA Label Image

Fig5 (Risedronate Fig5)

Fig5 (Risedronate Fig5)
Bar chart titled "Incidence of Vertebral Fractures in Patients Initiating or Continuing Glucocorticoid Therapy" compares incidence percentages between placebo and Risedronate Sodium 5 mg groups. The chart shows three categories: patients continuing glucocorticoid treatment, patients initiating glucocorticoid treatment, and combined patients, with sample sizes noted for each group.*
FDA Label Image

Figure 6 (Risedronate Fig6)

Figure 6 (Risedronate Fig6)
A line graph titled 'Mean Percent Change from Baseline in Serum Alkaline Phosphatase Excess by Visit' comparing two treatment groups: DIDRONEL 400 mg (open circles) and Risedronate Sodium 30 mg (filled squares). The x-axis represents visit days divided into Treatment, Follow-Up, and Extended Follow-Up phases up to 600 days. The y-axis shows percentage change from 20% to -120%. The graph includes sample sizes (n) at various time points for each group.*
FDA Label Image

Package Label-principal Display Panel (150 mg Blister Card (1 Unit-of-use))

Package Label-principal Display Panel (150 mg Blister Card (1 Unit-of-use))
Packaging label for Risedronate Sodium Tablet, USP 150 mg, film-coated oral tablet. The label indicates a one-month supply containing one tablet, distributed by Aurobindo Pharma USA, Inc. It includes child-resistant packaging instructions, storage conditions (20° to 25°C), and barcode. The product is made in India, with NDC 65862-870-11.*
FDA Label Image

Package Label-principal Display Panel (150 mg Blister Carton (1 Unit-of-use))

Package Label-principal Display Panel (150 mg Blister Carton (1 Unit-of-use))
Packaging label for Risedronate Sodium Tablet, USP 150 mg, an oral film-coated tablet by Aurobindo Pharma Limited. The label indicates a once-a-month dosage with a one-month supply of 1 tablet. Includes instructions for taking the tablet and distributor information for Aurobindo Pharma USA, Inc.*
FDA Label Image

Chemical Structure (Risedronate Str)

Chemical Structure (Risedronate Str)
Chemical structure of Risedronate Sodium showing the arrangement of its phosphonate, hydroxyl, pyridinyl, and sodium groups, along with two and a half water molecules (2.5 H2O) of hydration.*

* 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.