Amlodipine Besylate
Product Images NDC 67046-018

8 FDA label images from Contract Pharmacy Services-pa · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Amlodipine Besylate (NDC 67046-018). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Contract Pharmacy Services-pa, 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

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

8352ab43-figure-01 (8352ab43 Figure 01)
Chemical structure of Amlodipine Besylate, depicting its molecular arrangement including aromatic rings, chlorine atom, ester groups, and an aminomethyl side chain.*
FDA Label Image

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

8352ab43-figure-02 (8352ab43 Figure 02)
A Kaplan-Meier curve graph comparing event rates over time (in months) between Amlodipine and placebo groups. The graph shows cumulative event rates with time points marked from 0 to 24 months and includes a box inset displaying p-value, hazard ratio, and confidence interval statistics.*
FDA Label Image

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

8352ab43-figure-03 (8352ab43 Figure 03)
A forest plot graph comparing hazard ratios favoring Amlodipine versus placebo across various patient subgroups, including age, gender, baseline sitting systolic blood pressure, baseline vessel disease, vessel stenosis status, and PCI-stent strata. The x-axis represents hazard ratios with 95% confidence intervals, centered on a vertical line at 1.0, which indicates no effect.*
FDA Label Image

8352ab43-figure-05 (8352ab43 Figure 05)

8352ab43-figure-05 (8352ab43 Figure 05)
Amlodipine 5 mg tablet bottle label with a quantity of 30 tablets. The label includes lot number I1508169, pill ID IG 238, expiration date 11/02/16, and storage instructions to keep at 20°-25°C (68°-77°F). It is packaged by Contract Pharmacy Services-PA in Warrington, PA, with NDC 67046-018-30. The label advises to see the package insert for full prescribing information.*
FDA Label Image

8352ab43-figure-06 (8352ab43 Figure 06)

8352ab43-figure-06 (8352ab43 Figure 06)
A medication label for Amlodipine Besylate tablets, 10 mg strength, containing 30 tablets per package. The label includes storage instructions, mentions prescription use, and states that each tablet contains amlodipine besylate equivalent to 10 mg amlodipine. The labeler is Contract Pharmacy Services-PA, with a CPS NDC of 67046-019-30.*
FDA Label Image

Table1 (Tab1)

Table1 (Tab1)
A data table showing adverse event percentages for edema, dizziness, flushing, and palpitation in groups treated with Amlodipine at 2.5 mg, 5 mg, and 10 mg doses compared to a placebo group. Sample sizes are indicated for each group.*
FDA Label Image

Table2 (Tab2)

Table2 (Tab2)
A data table comparing the percentage incidence of fatigue, nausea, abdominal pain, and somnolence in subjects taking Amlodipine besylate tablets (N=1730) versus placebo (N=1250). The table shows higher percentages of these effects in the Amlodipine besylate group than in the placebo group.*
FDA Label Image

Table3 (Tab3)

Table3 (Tab3)
This table presents the frequency percentages of side effects (edema, flushing, palpitations, somnolence) in males and females taking amlodipine besylate tablets compared to those taking a placebo, with specific sample sizes indicated for each group.*

* 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.