Alendronate Sodium Tablet
Product Images NDC 16714-633

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Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Alendronate Sodium (NDC 16714-633). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rx 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.

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Figure 1 (Alendronate Fig1)

Figure 1 (Alendronate Fig1)
The text describes a chart showing the cumulative incidence of hip fractures over a period of 10% in a three-year study of patients with radiographic vertebral fracture at baseline. The chart compares the incidence between a placebo group and a group receiving Alendronate Sodium. The X-axis measures time in months.*
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Package Label-principal Display Panel (70 mg Blister Carton (5 Blister of 4 Tabletseach))

Package Label-principal Display Panel (70 mg Blister Carton (5 Blister of 4 Tabletseach))
Once Weekly Alendronate Sodium Tablets, USP is a medication used for treating osteoporosis. Each package contains 20 tablets, with 70mg of Alendronate Sodium per tablet. Pharmacists are required to dispense the tablets with a medication guide. The manufacturer of the tablets is Northstar, with an NDC number of 16714-633-02.*
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Figure 2 (Alendronate Fig2)

Figure 2 (Alendronate Fig2)
This text appears to be a table displaying the mean percentage increase in bone mineral density (BMD) seen in osteoporosis treatment studies in postmenopausal women. The specific treatment being studied is alendronate, at a dose of 10 mg/day for three years. The table displays the percentage increase in BMD at the lumbar spine, femoral neck, and trochanter sites, as well as a row labeled "V72 vss." which is not clear what it represents.*
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Figure 3 (Alendronate Fig3)

Figure 3 (Alendronate Fig3)
This is a table presenting the results of a study on Osteoporosis treatment in postmenopausal women. The table shows the Mean % Change From Baseline + SE for the Lumbar Spine BMD (Bone Mineral Density) and the time course of the effect of Alendronate 10 mg/day versus Placebo. The study was a Multinational study and lasted for 36 months. The first group was given Alendronate 10 mg/day, and the second group was a Placebo group. The table shows the Lumbar Spine BMD Percent Change From Baseline at 0, 12, 24, and 36 months for both groups.*
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Figure 4 (Alendronate Fig4)

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Studies In Glucocorticoid (Treated Patients Increase in BMD Alendronate 5 mg/day at One Year)

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Studies In Paget's Disease Of Bone Effect On Serum Alkaline Phosphatase Of Alendronate 40 mg/day Versus Placebo Or Etidronate 400 mg/day (Alendronate Fig6)

Studies In Paget's Disease Of Bone Effect On Serum Alkaline Phosphatase Of Alendronate 40 mg/day Versus Placebo Or Etidronate 400 mg/day (Alendronate Fig6)
This is a chart showing the effect of Alendronate 40 mg/day, Etidronate 400 mg/day, and Placebo on Serum Alkaline Phosphatase in patients with Paget's Disease of Bone. The chart displays the mean % change from baseline over time (up to 6 months). The multinational study consisted of patients receiving Alendronate 40 mg/day and had 27 participants, while the U.S. study had 41 participants receiving Alendronate 40 mg/day. The chart shows a significant decrease in serum alkaline phosphatase levels with Alendronate 40 mg/day as compared to placebo or Etidronate 400 mg/day.*
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Package Label-principal Display Panel (10 mg (30 Tablets Bottle))

Package Label-principal Display Panel (10 mg (30 Tablets Bottle))
This is a description for Alendronate Sodium tablets sold by Northstar Rx LLC. Each tablet contains 13.052 mg alendronate sodium USP equivalent to 10 mg alendronic acid. The usual adult dose is 10 mg once a day. The tablets should be stored at temperatures between 20°C to 25°C (68°F to 77°F). Pharmacists are instructed to dispense medication guides to each patient. The medication guide contains important instructions for use. The tablets come in a well-closed container and can be purchased in a pack of 30. Contact information for Northstar Rx LLC is available on their website or by calling 1-800-206-7821. The product is manufactured by Aurobindo Pharma Limited in Hyderabad, India.*
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Package Label-principal Display Panel (10 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (10 mg Blister Carton (10 x 10 Unit-dose))
This is a description of a medication for Alendronate Sodium Tablets, USP. The package contains 100 unit-dose tablets, with each tablet containing 13.052 mg alendronate sodium USP equivalent to 10 mg alendronic acid. The usual adult dosage is 10 mg once a day. The package is child-resistant, and the medication guide is included for each patient. The medication can be stored at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F). The medication is manufactured in India, and the Medication Guides are available at www.northstarrlic.com/products, or by calling 1-800-206-7821.*
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Package Label-principal Display Panel (35 mg Blister Carton (5 Blister of 4 Tablets each))

Package Label-principal Display Panel (35 mg Blister Carton (5 Blister of 4 Tablets each))
This is a package insert for Alendronate Sodium Tablets, USP with a dosage strength of 35 mg. The tablets are taken orally once a week. The package contains 20 tablets, which are arranged in 5 blisters containing 4 tablets each. The pharmacist is advised to dispense the accompanying Medication Guide to each patient. The NDC (National Drug Code) number is 16714-632-02.*
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Chemical Structure (Alendronate Str)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.