Alendronate Sodium Tablet
Product Images NDC 71205-048

8 FDA label images from Proficient Rx Lp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Alendronate Sodium (NDC 71205-048). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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 (Alendronate Fig1)

Figure 1 (Alendronate Fig1)
A line graph showing cumulative incidence of hip fractures over 36 months in a three-year study comparing Alendronate Sodium and placebo in patients with radiographic vertebral fracture at baseline. The x-axis represents time in months, and the y-axis shows cumulative incidence percentage. The Alendronate Sodium group has a lower incidence compared to placebo over time.*
FDA Label Image

71205-048-04 (Alendronate Fig10)

71205-048-04 (Alendronate Fig10)
Label for Alendronate Sodium 70 mg tablets, once weekly oral dosage form. The label indicates a package of 1x4 tablets, relabeled by Proficient Rx LP, Thousand Oaks, CA. It includes product details such as the product ID, manufacturer (Aurobindo Pharma Limited, India), storage instructions, and tablet description as white to off-white, oval, biconvex, uncoated tablets debossed with 'F' on one side and '21' on the other.*
FDA Label Image

Figure 2 (Alendronate Fig2)

Figure 2 (Alendronate Fig2)
A bar chart titled 'Osteoporosis Treatment Studies in Postmenopausal Women Increase in BMD Alendronate 10 mg/day at Three Years' showing mean percentage increase in bone mineral density (BMD) relative to placebo at lumbar spine, femoral neck, and trochanter sites. Data compare U.S. and multinational study groups with error bars representing standard error.*
FDA Label Image

Figure 3 (Alendronate Fig3)

Figure 3 (Alendronate Fig3)
A figure showing two line graphs that compare the effect of Alendronate 10 mg daily versus placebo on lumbar spine bone mineral density (BMD) percent change from baseline over 36 months in postmenopausal women. The left graph presents results from a U.S. study, and the right graph from a multinational study, with BMD percent change on the Y-axis and time in months on the X-axis. Alendronate shows a positive increasing effect on BMD compared to placebo in both studies.*
FDA Label Image

Figure 4 (Alendronate Fig4)

Figure 4 (Alendronate Fig4)
A chart comparing change in bone mineral density (BMD) from baseline in postmenopausal women over a 2-year study and a 3-year study. The graphs show mean percent change in BMD at lumbar spine, femoral neck, trochanter, and total body for Alendronate 5 mg/day versus placebo groups. Alendronate groups show positive BMD changes, while placebo groups show decreases.*
FDA Label Image

Figure 5 (Alendronate Fig5)

Figure 5 (Alendronate Fig5)
A bar graph showing the mean percentage increase in bone mineral density (BMD) relative to placebo in glucocorticoid-treated patients after one year of Alendronate 5 mg/day treatment. It compares results between U.S. and multinational groups at three sites: lumbar spine, femoral neck, and trochanter. The U.S. data are represented by hatched bars and multinational data by solid bars, with error bars indicating standard error.*
FDA Label Image

Figure 6 (Alendronate Fig6)

Figure 6 (Alendronate Fig6)
A line graph from studies in Paget's Disease of Bone showing the effect on serum alkaline phosphatase of Alendronate 40 mg/day compared to placebo or Etidronate 400 mg/day. The y-axis represents mean percent change from baseline in serum alkaline phosphatase, and the x-axis represents time in months (0, 3, 6). Data are shown for placebo, Etidronate, Alendronate multinational study, and Alendronate U.S. study groups with sample sizes noted.*
FDA Label Image

Chemical Structure (Alendronate Str)

Chemical Structure (Alendronate Str)
Chemical structure of Alendronate Sodium, showing its molecular formula with amine group, carbon chain, phosphate groups, sodium ion, and associated water molecules.*

* 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.