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)

This text provides information related to Amlodipine Besylate 10mg tablets. It includes details about the product, manufacturer, usage directions, and precautions. The text also mentions a comparison to NORVASC and contact information for reporting any adverse effects. The text is accompanied by an inset that likely contains additional information on prescribing.*

FDA Label Image

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

FDA Label Image

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

This appears to be a graph showing event rates over time, with months on the x-axis and event rate on the y-axis. There is also a P-value of 0.003 listed, as well as a hazard ratio of 0.691 and the mention of the drug Amiodipie. However, without additional context it is difficult to provide a more specific description or interpretation of the information presented.*

FDA Label Image

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

This text is discussing the comparison between the effectiveness of Amlodipine and Placebo. The text implies some sort of data analysis performed on a sample size of 333 individuals over the age of 65. Additionally, it presents a graph with unclear data along with a baseline sitting SBP value of 120 mmHg.*

FDA Label Image

Table1 (Tab1)

This appears to be a table showing the adverse effects of different dosages of Amlodipine and a placebo. The first column lists the possible side effects - edema, dizziness, flushing, and palpitation. The next columns list the dosage, number of participants (N), and the percentage of participants who experienced each side effect for each dosage or placebo. The data suggests that the likelihood of experiencing side effects increases with higher dosages of Amlodipine.*

FDA Label Image

Table2 (Tab2)

This is a table showing the percentage of patients who experienced certain side effects while taking Amlodipine besylate tablets versus a placebo in a clinical trial. The side effects reported are fatigue, nausea, abdominal pain, and somnolence.*

FDA Label Image

Table3 (Tab3)

This appears to be a list of symptoms and their occurrence in patients taking Amlodipine Besylate tablets compared to a placebo group, broken down by gender. The symptoms listed are edema, flushing, palpitations, and somnolence. The percentages represent the proportion of males and females in the study experiencing each symptom with the drug versus the placebo.*

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