Alendronate Sodium Solution
Product Images NDC 70954-264

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Alendronate Sodium (NDC 70954-264). 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

Study (Study)

Two line graphs comparing mean percent change in bone mineral density (BMD) from baseline over time (months) in U.S. and multinational studies. Each graph shows data for Alendronate 10 mg and placebo groups, with Alendronate demonstrating an increase in BMD while placebo remains near baseline.*

FDA Label Image

Carton (Carton)

Alendronate Sodium Oral Solution 70 mg/75 mL packaging label for single-dose bottles, labeled for once weekly use. Manufactured by Novitium Pharma LLC, the carton holds 4 single-dose bottles of 75 mL each. The label includes dosing instructions, storage information, inactive ingredients, and advises dispensing the enclosed Medication Guide to patients.*

FDA Label Image

Study-1 (Clinical Study 1)

A line graph comparing cumulative incidence percentages over time (up to 36 months) between placebo and Alendronate treatments. The x-axis represents time in months, and the y-axis shows cumulative incidence percentage. The graph includes two lines: a dashed line for placebo and a solid line for Alendronate.*

FDA Label Image

Study-5 (Clinical Study 5)

Bar graph showing mean percentage increase in bone mineral density (BMD) relative to placebo with standard error bars at three anatomical sites: lumbar spine, femoral neck, and trochanter. Data compares results for U.S. and multinational groups, with U.S. values consistently higher at all sites.*

FDA Label Image

Study-6 (Clinical Study 6)

A line graph depicting the effect on serum alkaline phosphatase levels over 6 months in studies on Paget's Disease of Bone. It compares placebo, Etidronate 400 mg/day, and Alendronate 40 mg/day in multinational and U.S. studies, showing mean percentage change from baseline with sample sizes indicated for each group.*

FDA Label Image

Container (Container)

Label for Alendronate Sodium Oral Solution 70 mg/75 mL, a prescription oral solution by ANI Pharmaceuticals, Inc. The label indicates a 75 mL bottle containing 91.35 mg alendronate sodium USP (70 mg free acid equivalent) per bottle, with instructions for once weekly dosing. The label includes manufacturer details as Novitium Pharma LLC, storage instructions, and a barcode.*

FDA Label Image

Figure-2 (Figure2)

A bar chart comparing mean percentage increase in bone mineral density (BMD) relative to placebo at three anatomical sites (Lumbar Spine, Femoral Neck, Trochanter) for U.S. and Multinational groups. Error bars indicate standard error for each measurement.*

FDA Label Image

Structure (Structure)

Chemical structure of Alendronate Sodium heptahydrate, showing its bisphosphonate backbone with amino and hydroxyl groups and three water molecules of hydration.*

FDA Label Image

Study-4 (Study 4)

Two bar graphs titled 'Osteoporosis Prevention Studies in Postmenopausal Women' showing mean percent change in bone mineral density (BMD) from baseline. The left graph represents a 2-year study and the right a 3-year study. Each graph compares Alendronate 5 mg/day and placebo effects on BMD at lumbar spine, femoral neck, trochanter, and total body. Bars indicate BMD increases with Alendronate and decreases with placebo in all categories.*

* 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.