Alendronate Sodium Tablet
Product Images NDC 16714-632

11 FDA label images from Northstar Rx Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Alendronate Sodium (NDC 16714-632). 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)
A line chart depicting the cumulative incidence of hip fractures over a 36-month period in a three-year study of FIT among patients with radiographic vertebral fractures at baseline. Two lines compare Placebo and Alendronate Sodium groups, showing lower cumulative incidence percentages for Alendronate Sodium at each time point.*
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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))
Alendronate Sodium Tablets, USP 70 mg oral tablets packaging label. This label shows a prescription drug by NorthStar Rx LLC, containing 20 tablets divided into 5 blisters with 4 tablets each. The label features dosing instructions as once weekly and instructs pharmacists to dispense the accompanying medication guide.*
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Figure 2 (Alendronate Fig2)

Figure 2 (Alendronate Fig2)
Bar chart titled 'Osteoporosis Treatment Studies in Postmenopausal Women' showing increase in bone mineral density (BMD) at three years with Alendronate 10 mg/day. The chart compares BMD percent increases at lumbar spine, femoral neck, and trochanter for U.S. and multinational study groups.*
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Figure 3 (Alendronate Fig3)

Figure 3 (Alendronate Fig3)
Two line graphs showing osteoporosis treatment studies in postmenopausal women. They compare the effect of Alendronate 10 mg/day versus placebo on lumbar spine bone mineral density (BMD) percent change from baseline over 36 months. One graph represents a U.S. study, the other a multinational study, illustrating mean percentage BMD changes with time.*
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Figure 4 (Alendronate Fig4)

Figure 4 (Alendronate Fig4)
Two bar graphs titled "Osteoporosis Prevention Studies in Postmenopausal Women" showing mean percent change in bone mineral density (BMD) from baseline. The left graph depicts a 2-year study, the right a 3-year study. Each compares Alendronate 5 mg/day to placebo across lumbar spine, femoral neck, trochanter, and total body sites, with Alendronate showing positive BMD changes and placebo showing declines.*
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Studies In Glucocorticoid (Treated Patients Increase in BMD Alendronate 5 mg/day at One Year)

Studies In Glucocorticoid (Treated Patients Increase in BMD Alendronate 5 mg/day at One Year)
A bar chart showing the increase in bone mineral density (BMD) at one year in glucocorticoid-treated patients taking Alendronate 5 mg per day. It compares the mean percentage increase in BMD relative to placebo with standard error bars, across three anatomical sites: Lumbar Spine, Femoral Neck, and Trochanter for U.S. and Multinational patient groups.*
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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)
A line graph depicting the effect of Alendronate 40 mg/day versus placebo and Etidronate 400 mg/day on serum alkaline phosphatase levels in Paget's Disease of Bone over a 6-month period. The y-axis shows mean percentage change from baseline, and the x-axis shows time in months. Data points for placebo, Etidronate, and two Alendronate studies (Multinational and U.S.) are shown with respective sample sizes.*
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Package Label-principal Display Panel (10 mg (30 Tablets Bottle))

Package Label-principal Display Panel (10 mg (30 Tablets Bottle))
Alendronate Sodium Tablets, USP 10 mg oral tablets label with NDC 16714-631-01. The label indicates 30 tablets per container, manufactured for NorthStar Rx LLC, Memphis, TN, and by Aurobindo Pharma Limited, India. It includes storage instructions and a barcode on the right side, along with a coding area marked for overprinting. The label highlights dispensing the medication guide to patients.*
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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))
Packaging label for Alendronate Sodium Tablets, USP 10 mg by NorthStar Rx LLC. The label shows a 100-count supply of unit-dose tablets (10 x 10). It includes storage instructions, manufacturer information (Aurobindo Pharma Limited, India), and a barcode. The label emphasizes dispensing the medication guide and notes the package is child-resistant.*
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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))
Alendronate Sodium Tablets, USP 35 mg oral tablets packaging label from NorthStar Rx LLC. The label indicates a once weekly dosage with 20 tablets (5 blisters of 4 tablets each) per package. It includes pharmacy dispensing instructions and medication guide information. The label also displays the NDC 16714-632-02 and product handling details.*
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Chemical Structure (Alendronate Str)

Chemical Structure (Alendronate Str)
Chemical structure of Alendronate Sodium, showing its molecular arrangement with amine, carbon, and phosphate groups, including sodium and water of hydration (3H2O).*

* 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.