Eplerenone
Product Images NDC 42254-011

7 FDA label images from Rebel Distributors Corp. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Eplerenone (NDC 42254-011). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rebel Distributors Corp., 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

Chemical Structure (4743a48b D4b5 4054 85e1 9d64cc40de25 01)

Chemical Structure (4743a48b D4b5 4054 85e1 9d64cc40de25 01)
Chemical structure diagram of eplerenone showing a steroidal backbone with labeled functional groups, including ketone and ester moieties, consistent with the active ingredient eplerenone.*
FDA Label Image

Figure 1 (4743a48b D4b5 4054 85e1 9d64cc40de25 02)

Figure 1 (4743a48b D4b5 4054 85e1 9d64cc40de25 02)
A line graph showing cumulative incidence percentage over 27 months since randomization comparing Eplerenone versus placebo. The graph plots two lines representing treatment groups with cumulative incidence on the vertical axis and months on the horizontal axis. Data points include the number of patients at risk for each treatment group at different time intervals.*
FDA Label Image

Figure 2a (4743a48b D4b5 4054 85e1 9d64cc40de25 03)

Figure 2a (4743a48b D4b5 4054 85e1 9d64cc40de25 03)
A two-part forest plot chart depicting hazard ratios with 95% confidence intervals for overall mortality in patients using Eplerenone compared to placebo. The first chart breaks down mortality by age groups, gender, and race, while the second chart categorizes mortality by diabetes status, hypertension presence, and Killip classification. Each group displays total number of events and patients analyzed, with a horizontal axis indicating favorability between Eplerenone and placebo.*
FDA Label Image

Figure 2b (4743a48b D4b5 4054 85e1 9d64cc40de25 04)

Figure 2b (4743a48b D4b5 4054 85e1 9d64cc40de25 04)
Two forest plots depicting overall mortality by subgroups for the drug Eplerenone compared to placebo. The first plot stratifies by creatinine clearance levels, and the second by baseline use of beta blockers, ACE inhibitors, digoxin, and diuretics. Each plot shows hazard ratios with confidence intervals, total number of events, and number of patients in each subgroup.*
FDA Label Image

Figure 3 (4743a48b D4b5 4054 85e1 9d64cc40de25 05)

Figure 3 (4743a48b D4b5 4054 85e1 9d64cc40de25 05)
A scatter plot chart showing the reduction in systolic blood pressure (SBP) in mmHg on the vertical axis against different doses of Eplerenone tablets in mg/day on the horizontal axis. The chart includes data points from two studies with three dosing regimens: Study 1 once daily (QD), Study 2 once daily (QD), and Study 2 twice daily (BID).*
FDA Label Image

Figure 4 (4743a48b D4b5 4054 85e1 9d64cc40de25 06)

Figure 4 (4743a48b D4b5 4054 85e1 9d64cc40de25 06)
A scatter plot chart showing the reduction in diastolic blood pressure (DBP) in mmHg on the vertical axis versus Eplerenone tablet dose in mg/day on the horizontal axis. Data points correspond to three studies: Study 1 QD (once daily), Study 2 QD (once daily), and Study 2 BID (twice daily), each represented by different markers. The chart depicts the relationship between Eplerenone dosage and its effect on lowering DBP.*
FDA Label Image

Eplerenone 50mg (4743a48b D4b5 4054 85e1 9d64cc40de25 07)

Eplerenone 50mg (4743a48b D4b5 4054 85e1 9d64cc40de25 07)
Label for Eplerenone 50 mg tablets, with a quantity of 90 tablets. The label shows the product name, strength, and quantity, including the NDC 42254-011-90. It states each tablet contains 50 mg Eplerenone and describes the tablets as round, yellow, film-coated with debossing "S2" on one side and "16" on the other. The label lists the manufacturer as Sandoz Inc., Princeton, NJ, and distributor as Physician Partner, Thousand Oaks, CA. Storage instructions recommend controlled room temperature 15°-30°C (59°-86°F). The label also includes lot and expiration placeholders, barcode, and regulatory information.*

* 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.