Alendronate Sodium Tablet
Product Images NDC 65862-327

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Alendronate Sodium (NDC 65862-327). 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.

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Figure 1 (Alendronate Fig1)

A line graph showing the cumulative incidence percentage of hip fractures over a 36-month period in a three-year study of FIT. It compares placebo (dashed line) and Alendronate Sodium (solid line) in patients with radiographic vertebral fractures at baseline, with cumulative incidence increasing more slowly for the Alendronate Sodium group.*

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Package Label-principal Display Panel (70 mg Blister Carton (4 Unit-of-use))

Packaging label for Alendronate Sodium Tablets, USP 70 mg, once weekly dosage form. The label states it contains 4 tablets and is distributed by Aurobindo Pharma USA, Inc. The label includes dosing instructions, storage information, and a medication guide reminder. It also features the Aurobindo logo and visual instructions for removing the tablets from the blister pack.*

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Figure 2 (Alendronate Fig2)

A bar chart titled 'Osteoporosis Treatment Studies in Postmenopausal Women Increase in BMD' showing the mean percent increase in bone mineral density (BMD) relative to placebo for Alendronate 10 mg/day at three years. The chart compares U.S. and multinational study results at three anatomical sites: Lumbar Spine, Femoral Neck, and Trochanter, with U.S. data consistently higher at each site.*

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Figure 3 (Alendronate Fig3)

A dual-panel line graph comparing the time course effect of Alendronate 10 mg/day versus placebo on lumbar spine BMD percent change from baseline in postmenopausal women. The left panel shows data from a U.S. study, and the right panel from a multinational study. Both display BMD mean percent change with standard error over 36 months, with Alendronate showing increasing positive change and placebo remaining near baseline.*

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Figure 4 (Alendronate Fig4)

Two bar charts comparing the mean percentage change in bone mineral density (BMD) from baseline in postmenopausal women in osteoporosis prevention studies. The left chart shows results from a 2-year study and the right chart from a 3-year study, each comparing Alendronate 5 mg/day with placebo at lumbar spine, femoral neck, trochanter, and total body sites.*

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Figure 5 (Alendronate Fig5)

A bar chart comparing mean percentage increase in bone mineral density (BMD) over one year at three anatomical sites (Lumbar Spine, Femoral Neck, Trochanter) in glucocorticoid-treated patients taking Alendronate 5 mg/day. Two patient groups are shown: U.S. and Multinational, with error bars representing standard error.*

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Figure 6 (Alendronate Fig6)

A line graph showing the effect on serum alkaline phosphatase in studies of Paget's Disease of Bone comparing Alendronate 40 mg/day, Etidronate 400 mg/day, and placebo over 6 months. The y-axis shows mean percentage change from baseline with standard error, and the x-axis shows time in months. Data points for placebo, etidronate, and two Alendronate studies (multinational and U.S.) show decreasing levels of serum alkaline phosphatase for active treatments compared to placebo.*

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Package Label-principal Display Panel (10 mg (30 Tablets Bottle))

Alendronate Sodium Tablets USP 10 mg label from Aurobindo Pharma Limited. The packaging states the active ingredient strength as 10 mg alendronate sodium per tablet, with a package size of 30 tablets. Distributed by Aurobindo Pharma USA, Inc., made in India. Includes storage instructions and a note to dispense the accompanying Medication Guide to patients.*

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Package Label-principal Display Panel (10 mg Blister Carton 100 (10 x 10) Unit-dose Tablets)

Packaging label for Alendronate Sodium Tablets, USP 10 mg by Aurobindo Pharma Limited. The label indicates the product contains 100 unit-dose tablets (10 x 10). It features dosing information, storage instructions, and a space for prescription label. Distributed by Aurobindo Pharma USA, Inc., made in India.*

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Package Label-principal Display Panel (35 mg Blister Carton (4 Unit-of-use))

Packaging label for Alendronate Sodium Tablets, USP 35 mg by Aurobindo Pharma. The label indicates the product is taken once weekly with instructions for use and removal of tablets. The package contains 4 tablets and is marked Rx only. Distributor information is included, specifying Aurobindo Pharma USA, Inc. with a New Jersey address. The label features a barcode and space for applying a prescription label.*

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Chemical Structure (Alendronate Str)

Chemical structure of Alendronate Sodium showing its molecular components including amino 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.