Alendronate Sodium
Product Images NDC 68258-3014

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Alendronate Sodium (NDC 68258-3014). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dispensing Solutions 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

Label Image For 70mg 4 Count Bottle (Ndc 68258 3014 01)

Label for Alendronate Sodium 70 mg tablets by Dispensing Solutions Inc., containing 4 tablets. The label includes NDC 68258-3014-01, product number 5A0244, and indicates the tablets contain 91.37 mg Alendronate Sodium USP (70 mg free acid equivalent). It advises storage between 68°-77°F and features warnings to keep out of children's reach. The label references Cobalt Laboratories as manufacturer and includes handling instructions.*

FDA Label Image

Figure (Figure02)

A bar graph depicting percent increase in bone mineral density (BMD) including standard error at three anatomical sites: Lumbar Spine, Femoral Neck, and Trochanter. Data are compared between U.S. and Multinational groups, showing higher mean increases in the U.S. group at all sites.*

FDA Label Image

Figure (Figure06)

A bar chart comparing mean percentage increases in bone mineral density (BMD) relative to placebo plus standard error for U.S. and Multinational groups at three anatomical sites: Lumbar Spine, Femoral Neck, and Trochanter. The graph features error bars indicating variability in the data for each group and site.*

FDA Label Image

Figure (Figure1and2)

Two line graphs comparing bone mineral density (BMD) percent change from baseline over 36 months for Alendronate Sodium 10 mg versus placebo. The left graph, titled U.S. Study, shows a higher BMD increase with Alendronate Sodium compared to placebo. The right graph, titled Multinational Study, also shows greater BMD increase for Alendronate Sodium than placebo over time.*

FDA Label Image

Figure (Figure3)

A line graph showing cumulative incidence (%) over time in months up to 36 months, comparing Alendronate Sodium (solid line) to Placebo (dashed line). The graph illustrates the trend of incidence rates between the two groups throughout the study period.*

FDA Label Image

Figure (Figure4and5)

A set of two bar charts comparing percentage changes in bone mineral density (BMD) from baseline between Alendronate Sodium 5mg/day and placebo groups. The left chart shows data for a 2-year study across lumbar spine, femoral neck, trochanter, and total body, while the right chart shows similar data for a 3-year study at the same skeletal sites.*

FDA Label Image

Figure (Figure6)

A line graph showing serum alkaline phosphatase mean percent change from baseline with standard error bars over 0, 3, and 6 months. It compares Placebo, Etidronate 400 mg/day, and Alendronate Sodium 40 mg/day from two studies (multinational and U.S.). Sample sizes (N) for each group at 6 months are indicated.*

FDA Label Image

Fosamax_structure (Fosamax 01)

Chemical structure of Alendronate Sodium depicting its molecular arrangement including phosphate groups, hydroxyl, and sodium ion, shown with 3 molecules of water of hydration (trihydrate form).*

* 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.