Alendronate Sodium Tablet
Product Images NDC 0115-1681

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Alendronate Sodium (NDC 0115-1681). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Of New York Llc, 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

Image Of Alendronate Sodium Chemical Structure (Alendronate Sodium Tablets 1)

Chemical structure of Alendronate Sodium, showing its detailed molecular arrangement including phosphonate groups and sodium salt form with three water molecules (3H2O).*

FDA Label Image

5mg-30tabs (Alendronate Sodium Tablets 10)

Label for Alendronate Sodium Tablets USP 5 mg, a prescription oral tablet. The label states the tablet contains 5 mg of alendronate sodium, providing 4.37 mg of alendronic acid equivalent. It includes storage instructions, warnings to keep out of reach of children, and pharmacist dispensing information. The labeler is Amneal Pharmaceuticals of New York LLC, with manufacturing in Croatia and distribution in Hayward, CA. The package contains 30 tablets.*

FDA Label Image

10mg-30tabs (Alendronate Sodium Tablets 11)

Alendronate Sodium Tablets USP 10 mg bottle label showing the product strength and form. The label indicates 30 tablets per bottle for oral administration. It includes usage instructions and storage conditions, with manufacturing and distributor details by Amneal Pharmaceuticals of New York LLC and Impax Laboratories. The National Drug Code (NDC) is 0115-1678-08.*

FDA Label Image

35mg-4tabs (Alendronate Sodium Tablets 12)

Packaging label for Alendronate Sodium Tablets USP 35 mg, oral tablets supplied in a carton of 4 tablets. The label indicates the product is for once weekly dosing and is manufactured by Pliva Hrvatska d.o.o., distributed by Impax Generics. The label includes dosage instructions, storage conditions, and a barcode.*

FDA Label Image

40mg-30tabs (Alendronate Sodium Tablets 13)

Label for Alendronate Sodium Tablets USP 40 mg oral tablets, packaged as 30 tablets. The label includes usage instructions, active ingredient amount per tablet, storage conditions, and warnings. It is labeled for dispensing with medication guide and is from Amneal Pharmaceuticals of New York LLC, manufactured by Hetero Healthcare in India.*

FDA Label Image

70mg-4tabs (Alendronate Sodium Tablets 14)

Alendronate Sodium Tablets USP 70 mg oral tablet packaging label from Amneal Pharmaceuticals of New York LLC. The carton contains 4 tablets for once weekly use. The label includes dosage instructions, storage conditions, manufacturer details (PLIVA HRVATSKA d.o.o., Croatia), and distributor (Impax Generics, Hayward, CA). The product is for prescription use only.*

FDA Label Image

Figure 1 (Alendronate Sodium Tablets 2)

A line graph comparing cumulative incidence percentages over 36 months between Alendronate Sodium and placebo groups. The x-axis represents time in months (0 to 36), and the y-axis represents cumulative incidence percentage (0% to 10%). The graph includes a solid line for Alendronate Sodium and a dashed line for placebo, showing lower cumulative incidence for Alendronate Sodium throughout the period.*

FDA Label Image

Figure 2 (Alendronate Sodium Tablets 3)

A bar chart comparing bone mineral density (BMD) mean percentage increases relative to placebo plus standard error in three anatomical sites: lumbar spine, femoral neck, and trochanter. Two groups are displayed: U.S. and Multinational, with the U.S. group showing higher increases in lumbar spine and trochanter regions.*

FDA Label Image

Figure 3a (Alendronate Sodium Tablets 4)

Line graph titled 'U.S. Study' compares mean percentage change from baseline in Bone Mineral Density (BMD) over 36 months for Alendronate 10 mg (free acid) versus placebo. The graph shows BMD increasing steadily for Alendronate while remaining near baseline for placebo, with error bars displayed at each time point.*

FDA Label Image

Figure 3b (Alendronate Sodium Tablets 5)

A line graph from a multinational study comparing mean percent change in bone mineral density (BMD) from baseline over 36 months between Alendronate 10 mg and placebo. The graph shows Alendronate consistently increasing BMD, while placebo remains near baseline.*

FDA Label Image

Figure 4a (Alendronate Sodium Tablets 6)

A bar graph depicting the change in bone mineral density (BMD) from baseline over a 2-year study comparing Alendronate, free acid 5 mg/day, versus placebo. The graph shows mean percent changes with standard error for lumbar spine, femoral neck, trochanter, and total body, with Alendronate bars above zero and placebo bars below zero.*

FDA Label Image

Figure 4b (Alendronate Sodium Tablets 7)

A bar graph depicting the change in bone mineral density (BMD) from baseline over a 3-year study. It compares BMD percentage changes in lumbar spine, femoral neck, trochanter, and total body between Alendronate (free acid 5 mg/day) and placebo groups, showing mean percentage change with standard error bars.*

FDA Label Image

Figure 5 (Alendronate Sodium Tablets 8)

Bar chart showing mean percentage increase in bone mineral density (BMD) relative to placebo plus standard error (SE) for Alendronate Sodium. Results are compared between U.S. and multinational groups across three sites: lumbar spine, femoral neck, and trochanter.*

FDA Label Image

Figure 6 (Alendronate Sodium Tablets 9)

A line graph illustrating the mean percentage change from baseline in serum alkaline phosphatase over time (0, 3, and 6 months) with standard error bars for multiple groups: placebo, etidronate 400 mg/day, and alendronate (free acid) 40 mg/day from both multinational and U.S. studies. The graph shows distinct trends for each treatment group.*

* 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.