Amlodipine Besylate
Product Images NDC 12634-600

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Amlodipine Besylate (NDC 12634-600). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotheca 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

Label (600 71)

A packaging label for Amlodipine Besylate 10mg, tablets, with a package size of 30 tablets. The label shows the NDC 12634-600-71 and is distributed by Apotheca Inc., Phoenix, AZ. It includes lot and expiration date fields, directions for use, and manufacturer information for Invagen Pharmaceuticals, Inc., Hauppauge, NY. The label also details storage instructions and emphasizes child-resistant packaging.*

FDA Label Image

8352ab43-figure-01 (8352ab43 Figure 01)

Chemical structure of Amlodipine Besylate illustrating the arrangement of atoms, including a chlorophenyl group, ester groups, and an aminoalkyl side chain with molecular formula C20H25ClN2O5S.*

FDA Label Image

8352ab43-figure-02 (8352ab43 Figure 02)

A Kaplan-Meier curve comparing event rates over 24 months between Amlodipine and placebo groups. The graph plots event rate on the y-axis and time in months on the x-axis, showing lower event rates for Amlodipine compared to placebo, with a p-value of 0.003 and a hazard ratio of 0.691 (95% CI: 0.54-0.88).*

FDA Label Image

8352ab43-figure-03 (8352ab43 Figure 03)

A forest plot illustrating hazard ratios with 95% confidence intervals comparing Amlodipine Besylate versus placebo across patient subgroups. The categories include overall patients, age groups (<65, ≥65), gender, baseline sitting systolic blood pressure, baseline vessel disease, baseline vessels with stenosis, and PCI-stent strata, showing their relative favorability towards Amlodipine or placebo.*

FDA Label Image

Table1 (Tab1)

A data table displaying the incidence rates (in percentages) of adverse effects including edema, dizziness, flushing, and palpitation across different dosing groups of Amlodipine (2.5 mg, 5 mg, 10 mg) and a placebo group, with sample sizes (N) provided for each group.*

FDA Label Image

Table2 (Tab2)

A data table comparing the percentages of four side effects—fatigue, nausea, abdominal pain, and somnolence—between Amlodipine besylate tablets and placebo groups. The table includes sample sizes with 1,730 subjects for Amlodipine besylate and 1,250 for placebo.*

FDA Label Image

Table3 (Tab3)

A data table showing the percentage of males and females experiencing edema, flushing, palpitations, and somnolence during a clinical study comparing Amlodipine besylate tablets and placebo. It presents values for male and female subjects under both treatment and placebo conditions.*

* 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.