Amlodipine Besylate
Product Images NDC 12634-599

6 FDA label images from Apotheca Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Amlodipine Besylate (NDC 12634-599). 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 (599 71)

Label (599 71)
Amlodipine Besylate 2.5 mg label for 30 tablets by Apotheca Inc. The label includes the NDC 12634-599-71, lot and expiration date fields, and states the product is Rx only. It dispenses in a tight, light-resistant container with a child-resistant closure. Directions indicate to take the tablet(s) by mouth as directed by a physician with storage instructions at controlled room temperature.*
FDA Label Image

Chemical Structure (75496a09 3e64 4469 8456 4506706d3e83 01)

Chemical Structure (75496a09 3e64 4469 8456 4506706d3e83 01)
Chemical structure diagram of the active ingredient amlodipine besylate, showing the arrangement of atoms and functional groups in the molecule.*
FDA Label Image

Kaplan-meier Analysis Of Composite Clinical Outcomes For Amlodipine Versus Placebo Kaplan-meier Analysis Of Composite Clinical Outcomes For Amlodipine Versus Placebo Figure-02 (75496a09 3e64 4469 8456 4506706d3e83 02)

Kaplan-meier Analysis Of Composite Clinical Outcomes For Amlodipine Versus Placebo  Kaplan-meier Analysis Of Composite Clinical Outcomes For Amlodipine Versus Placebo 							 Figure-02 (75496a09 3e64 4469 8456 4506706d3e83 02)
A line graph comparing event rates over time (months) for Amlodipine and Placebo groups. The x-axis shows time in months up to 24, and the y-axis shows event rate from 0 to 0.25. The graph includes a statistical inset with a P-value of 0.003, hazard ratio of 0.691, and a 95% confidence interval range of 0.54 to 0.88. The number of subjects at risk is indicated below the time axis.*
FDA Label Image

Figure-03 (75496a09 3e64 4469 8456 4506706d3e83 03)

Figure-03 (75496a09 3e64 4469 8456 4506706d3e83 03)
A hazard ratio plot showing the efficacy comparison between Amlodipine and placebo across various patient subgroups, including age, gender, baseline sitting systolic blood pressure, baseline vessel disease, baseline vessels with stenosis, and PCI-stent strata. The horizontal axis represents the hazard ratio with a 95% confidence interval, demarcating favor towards Amlodipine on the left and placebo on the right.*
FDA Label Image

Company Logo (75496a09 3e64 4469 8456 4506706d3e83 04)

FDA Label Image

Company Logo (75496a09 3e64 4469 8456 4506706d3e83 05)

* 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.