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)

FDA Label Image

Image 1 (8352ab43 Figure 02)

This appears to be a chart or table with information related to an event rate. It includes a timeline along the bottom, labeled as "Time (Months)," and a P-value of 0.003. The hazard ratio is 0.691 and there appears to be a drug listed as "Amiodipie," although it is not clear what the other text is referring to. Without additional context or clarity, the information provided is not very useful.*

FDA Label Image

Image 2 (8352ab43 Figure 03)

This appears to be a comparison of the effectiveness of Amlodipine versus Placebo for individuals aged over 65, with data provided for 333 participants. However, the description includes limited information and is not comprehensive enough to draw any further conclusions. Lastly, the last statement mentions the baseline systolic blood pressure levels.*

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

This is a prescription medication called Amlodipine Besylate Tablet, USP 10mg, with 30 or 40 tablets per container. The dosage instructions are found in the package insert. It should be stored in a controlled room temperature environment, away from children. There are lot numbers and expiration dates specified. It is repackaged by Blenheim Pharmacal Inc for Camber Pharmaceuticals. There is an indication about the medication's composition, but it is not readable due to errors.*

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

This is a description of a medication named Amlodipine Besylate in tablet form. The medication is sold by Camber Pharmaceuticals Inc, and each bottle contains 30 tablets. The tablets are each 5mg and should be stored at a controlled room temperature of 20-25°C. They come in an airtight container to protect them from outside air. The package insert should be used to determine the dosage. The description also provides information about several other versions of the medication, each with slightly different details like their mg and lot numbers.*

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Table1 (Tab1)

This text presents data on the side effects of Amlodipine at different dosages (2.5mg, 5mg, and 10mg) compared to a placebo. The side effects measured were edema, dizziness, flushing, and palpitation. The number of participants (N), percentage of participants experiencing the side effects, and the numerical value of the percentage are given for each group.*

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Table2 (Tab2)

This is a table that compares the percentage of side effects experienced by two groups of people who took different medications. One group took Amlodipine besylate tablets and the other group took placebo (a fake medication). The table shows the percentage of people in each group who experienced fatigue, nausea, abdominal pain, and somnolence (feeling drowsy or sleepy). For example, 45% of people who took Amlodipine besylate tablets experienced fatigue, while only 2.8% of people who took placebo did. Similarly, 29% of people who took Amlodipine besylate tablets experienced nausea, compared to 19% of people who took placebo. Overall, it suggests that the Amlodipine besylate tablets were associated with a higher incidence of side effects compared to placebo.*

FDA Label Image

Table3 (Tab3)

This is a report on the side effects of a medication called Amlodipine besylate tablets. The percentage of male and female patients who experienced Edema, Flushing, Palpitations, and Somnolence after taking the medication is provided. The percentage of patients who experienced the same side effects while taking a placebo is also given.*

* 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.