Alendronate Sodium
Product Images NDC 54868-5862

12 FDA label images from Physicians Total Care, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Alendronate Sodium (NDC 54868-5862). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Physicians Total Care, Inc., 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

Alendronate Sodium Structural Formula (1752745b 35fd 4b7e B676 Bff3edd7e8ca 01)

Alendronate Sodium Structural Formula (1752745b 35fd 4b7e B676 Bff3edd7e8ca 01)
Chemical structure of Alendronate Sodium showing its molecular composition including phosphonate groups, amino group, carbon atoms, and associated waters of hydration.*
FDA Label Image

Figure 1 (1752745b 35fd 4b7e B676 Bff3edd7e8ca 02)

Figure 1 (1752745b 35fd 4b7e B676 Bff3edd7e8ca 02)
A bar graph comparing mean percentage increase in Bone Mineral Density (BMD) relative to placebo for U.S. and multinational groups at three anatomical sites: Lumbar Spine, Femoral Neck, and Trochanter. Bars display values with standard error.*
FDA Label Image

Figure 2 (1752745b 35fd 4b7e B676 Bff3edd7e8ca 03)

Figure 2 (1752745b 35fd 4b7e B676 Bff3edd7e8ca 03)
A line chart depicting a U.S. study comparing the mean percentage change from baseline in bone mineral density (BMD) over 36 months between Alendronate Sodium 10 mg and placebo groups. The graph shows time in months on the x-axis and BMD percentage change on the y-axis, with Alendronate Sodium group showing a steady increase while the placebo group remains near baseline.*
FDA Label Image

Osteoporosis Treatment Studies In Postmenopausal Women Time Course Of Effect Of Alendronate Sodium 10 mg/day Versus Placebo: Lumbar Spine Bmd Percent Change From Baseline (1752745b 35fd 4b7e B676 Bff3edd7e8ca 04)

Osteoporosis Treatment Studies In Postmenopausal Women Time Course Of Effect Of Alendronate Sodium 10 mg/day Versus Placebo: Lumbar Spine Bmd Percent Change From Baseline (1752745b 35fd 4b7e B676 Bff3edd7e8ca 04)
A line graph from a multinational study showing the mean percentage change in Bone Mineral Density (BMD) from baseline over 36 months. The graph compares Alendronate Sodium 10 mg treatment, represented by filled circles, with placebo, represented by open circles. The Alendronate Sodium group shows a steady increase in BMD over time, while the placebo group remains near baseline levels.*
FDA Label Image

Cumulative Incidence Of Hip Fractures In The Three-year Study Of Fit (patients With Radiographic Vertebral Fracture At Baseline) (1752745b 35fd 4b7e B676 Bff3edd7e8ca 05)

Cumulative Incidence Of Hip Fractures In The Three-year Study Of Fit (patients With Radiographic Vertebral Fracture At Baseline) (1752745b 35fd 4b7e B676 Bff3edd7e8ca 05)
A line graph comparing the cumulative incidence percentage over time in months for Alendronate Sodium versus Placebo. The graph shows two lines: a solid line for Alendronate Sodium and a dashed line for Placebo, with the x-axis labeled from 0 to 36 months and the y-axis from 0 to 10 percent cumulative incidence.*
FDA Label Image

Osteoporosis Prevention Studies In Postmenopausal Women (1752745b 35fd 4b7e B676 Bff3edd7e8ca 06)

Osteoporosis Prevention Studies In Postmenopausal Women (1752745b 35fd 4b7e B676 Bff3edd7e8ca 06)
A bar chart depicting the change in bone mineral density (BMD) from baseline over a 2-year study comparing Alendronate Sodium 5 mg/day to placebo. BMD changes are shown for the lumbar spine, femoral neck, trochanter, and total body, with Alendronate Sodium generally showing positive BMD changes, while placebo shows decreases.*
FDA Label Image

Osteoporosis Prevention Studies In Postmenopausal Women (1752745b 35fd 4b7e B676 Bff3edd7e8ca 07)

Osteoporosis Prevention Studies In Postmenopausal Women (1752745b 35fd 4b7e B676 Bff3edd7e8ca 07)
A bar graph titled "Change in BMD from Baseline 3 Year Study" comparing bone mineral density (BMD) mean percentage change plus standard error for Alendronate Sodium 5 mg/day versus placebo. The graph shows BMD changes at four body sites: Lumbar Spine, Femoral Neck, Trochanter, and Total Body, with Alendronate Sodium consistently showing positive BMD changes compared to negative changes for the placebo group.*
FDA Label Image

Figure 7 (1752745b 35fd 4b7e B676 Bff3edd7e8ca 08)

Figure 7 (1752745b 35fd 4b7e B676 Bff3edd7e8ca 08)
A bar chart comparing the mean percent increase in Bone Mineral Density (BMD) relative to placebo plus standard error across three anatomical sites: Lumbar Spine, Femoral Neck, and Trochanter. Data is shown for two groups: U.S. and Multinational, with Multinational consistently showing higher increases in BMD than the U.S. group at each site.*
FDA Label Image

Studies In Paget's Disease Of Bone Effect On Serum Alkaline Phosphatase Of Alendronate Sodium 40 mg/day Versus Placebo Or Etidronate 400 mg/day (1752745b 35fd 4b7e B676 Bff3edd7e8ca 09)

Studies In Paget's Disease Of Bone Effect On Serum Alkaline Phosphatase Of Alendronate Sodium 40 mg/day Versus Placebo Or Etidronate 400 mg/day (1752745b 35fd 4b7e B676 Bff3edd7e8ca 09)
A line graph displaying the mean percent change from baseline plus standard error in serum alkaline phosphatase over 6 months for placebo, etidronate 400 mg/day, and alendronate sodium 40 mg/day from two studies (multinational and U.S.). The x-axis represents time in months, and the y-axis represents serum alkaline phosphatase levels. Different symbols denote each treatment group with sample sizes indicated.*
FDA Label Image

Alendronate Sodium Tablets Usp 35 mg 4s Box (5860)

Alendronate Sodium Tablets Usp 35 mg 4s Box (5860)
Label for Alendronate Sodium 35 mg tablets distributed by Physicians Total Care, Inc., Tulsa, OK. The label includes the NDC number 54868-5060-0, lot number 0000, and expiration date 01/60. Manufactured by Teva Pharmaceuticals USA, Sellersville, PA. Barcode and number 58600040000 are also visible.*
FDA Label Image

Alendronate Sodium Tablets Usp 70 mg 4s Box (5861)

Alendronate Sodium Tablets Usp 70 mg 4s Box (5861)
Label for Alendronate Sodium 70mg tablets distributed by Physicians Total Care, Inc. The label includes the NDC number 54868-5861-0, lot number 0000, and an expiration date listed as 01/60. The manufacturer is Teva Pharmaceuticals USA. A barcode is also present below the text.*
FDA Label Image

Alendronate Sodium Tablets 10 mg 30s Label (5862)

Alendronate Sodium Tablets 10 mg 30s Label (5862)
Label for Alendronate Sodium 10 mg tablets distributed by Physicians Total Care, Inc. The label includes the NDC 54868-5862-0, lot number 0000, and an expiration date of 01/60. It also shows the manufacturer as TEVA Pharmaceuticals USA and a barcode with the number 58620300000.*

* 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.