Alendronate Sodium
Product Images NDC 67296-2054

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Alendronate Sodium (NDC 67296-2054). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Redpharm Drug, 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

Figure 1 (Alendronate Fig1)

This is a description of the cumulative incidence of hip fractures over a three-year study period comparing patients with radiographic vertebral fractures at baseline. The data presented show the cumulative incidence (%) over time for both placebo and alendronate sodium treatment groups.*

FDA Label Image

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

FDA Label Image

Package Label-principal Display Panel (70 mg (100 Tablets Bottle))

Each tablet contains 70 mg of alendronate sodium, distributed by Aurobindo Pharma USA, Inc. This medication is to be taken once weekly by adults and comes with an accompanying Medication Guide for important information. It is essential to read the guide before consuming the alendronate sodium tablets. The tablets should be stored at room temperature and kept out of reach of children. The pharmacist should dispense the Medication Guide along with the tablets. For more detailed dosage information, refer to the circular provided.*

FDA Label Image

Figure 2 (Alendronate Fig2)

This text provides information on the mean percentage increase in Bone Mineral Density (BMD) relative to placebo in osteoporosis treatment studies in postmenopausal women. It specifically mentions the increase in BMD for Alendronate 10 mg/day at three years for the lumbar spine, femoral neck, and trochanter regions.*

FDA Label Image

Figure 3 (Alendronate Fig3)

FDA Label Image

Figure 4 (Alendronate Fig4)

This text provides data on the mean percent change in Bone Mineral Density (BMD) from baseline in osteoporosis prevention studies conducted in postmenopausal women. It includes comparisons of the change in BMD over 2-year and 3-year studies between Alendronate 5 mg/day and Placebo in different bone regions such as Lumbar spine, Femoral neck, Trochanter, and Total body. The chart shows the results for both Alendronate and Placebo groups in these bone regions to evaluate the effectiveness of Alendronate in preventing osteoporosis.*

FDA Label Image

Figure 5 (Alendronate Fig5)

The text provides information on the mean percentage increase in Bone Mineral Density (BMD) in glucocorticoid-treated patients compared to a placebo. It mentions specific data related to BMD increase at different bone sites, such as lumbar spine, femoral neck, and trochanter, particularly when treated with Alendronate 5 mg/day for one year.*

FDA Label Image

Figure 6 (Alendronate Fig6)

This text provides information on the effect of Alendronate 40 mg/day on Serum Alkaline Phosphatase levels in studies involving Paget's Disease of Bone compared to Placebo or Etidronate 400 mg/day. The text includes data on the mean percentage change from baseline. The study involved a multinational study and a U.S. study with specific sample sizes for each group. Time points of 0, 3, and 6 months were assessed.*

FDA Label Image

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

This text provides information about a tablet containing 10 mg of alendronate sodium for adults. It includes details on dosage, storage conditions, and instructions for use. The tablets are distributed by Aurobindo Pharma USA, Inc. and come with an accompanying Medication Guide. Pharmacies are advised to dispense the Medication Guide to each patient separately. For more detailed information, the circular should be consulted. The tablets should be stored at room temperature.*

FDA Label Image

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

This text contains information about Alendronate Sodium Tablets, USP. The usual adult dosage is 10 mg once a day. The tablets contain 13,052 mg of lenonate sodium USP equivalent and 010 mg of alendronic acid. It also mentions important instructions for use and the availability of a Medication Guide. The unit-dose package is child-resistant. The tablets should be stored at 20° to 25° (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F). The NDC number for the tablets is 65862-327-10.*

FDA Label Image

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

FDA Label Image

Chemical Structure (Alendronate Str)

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