Amlodipine Besylate
Product Images NDC 10544-113

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Amlodipine Besylate (NDC 10544-113). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Blenheim Pharmacal, 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

Structure (8352ab43 Figure 01)

Chemical structure of Amlodipine Besylate, showing its molecular arrangement including aromatic rings, chlorine atom, ester groups, and the besylate moiety.*

FDA Label Image

Image 1 (8352ab43 Figure 02)

A Kaplan-Meier survival 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 with statistical details including a p-value of 0.003 and hazard ratio of 0.691 (95% CI: 0.54, 0.88). Number at risk is shown below the x-axis at various time points.*

FDA Label Image

Image 2 (8352ab43 Figure 03)

A forest plot chart comparing hazard ratios with 95% confidence intervals for Amlodipine Besylate versus placebo across various patient subgroups, including overall, age groups, gender, baseline sitting systolic blood pressure, baseline vessel disease, baseline vessels with stenosis, and PCI-stent strata. The horizontal axis ranges from 0.0 to 2.0, with a vertical line indicating neutrality at hazard ratio 1.0.*

FDA Label Image

Container Label 10mg (Label Amlodipine Tabs 10mg Bpi(10544 112 30) Camber(3722 239 10) Rev1)

A package label for Amlodipine Besylate Tablets, USP 10mg by Blenheim Pharmacal, Inc. The label states 30 tablets per container, Rx only, with storage instructions at controlled room temperature (20°-25°C). The label includes NDC 10544-112-30 and manufacturer code MFG 31722-239-10, along with batch and expiration placeholders.*

FDA Label Image

Container Label 5mg (Label Amlodipine Tabs 5mg Bpi(10544 113 30) Camber(3722 238 10) Rev1)

Amlodipine Besylate Tablets, USP 5 mg bottle label from Blenheim Pharmacal, Inc. The label indicates 30 tablets, prescription only, with storage instructions at controlled room temperature and in a tight, light-resistant container. It includes the NDC 10544-113-30 and manufacturer code 31722-238-10. The label shows lot and expiration date placeholders.*

FDA Label Image

Table1 (Tab1)

A data table showing the incidence of adverse events including edema, dizziness, flushing, and palpitation for Amlodipine at doses of 2.5 mg, 5 mg, 10 mg, and placebo groups with respective patient numbers listed. The table quantifies each event's occurrence percentage or frequency.*

FDA Label Image

Table2 (Tab2)

A data table presenting the percentage of patients experiencing fatigue, nausea, abdominal pain, and somnolence during treatment with Amlodipine besylate tablets versus placebo. The table compares reported side effects in patient groups of 1730 for Amlodipine besylate and 1250 for placebo.*

FDA Label Image

Table3 (Tab3)

A data table comparing the percentage incidence of side effects including edema, flushing, palpitations, and somnolence in male and female subjects taking amlodipine besylate tablets versus placebo. The table lists the number of subjects per group and the corresponding side effect percentages for each gender and treatment.*

* 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.