Isosorbide Dinitrate And Hydralazine Hydrochloride Tablet, Film Coated
Product Images NDC 52536-006

7 FDA label images from Wilshire Pharmaceuticals · 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 Isosorbide Dinitrate And Hydralazine Hydrochloride (NDC 52536-006). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Wilshire Pharmaceuticals, 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 (Isosorbide 01)

Chemical Structure (Isosorbide 01)
Chemical structure of isosorbide dinitrate, one of the active ingredients in the hydralazine hydrochloride and isosorbide dinitrate combination medication.*
FDA Label Image

Chemical Structure (Isosorbide 02)

Chemical Structure (Isosorbide 02)
Chemical structure diagram of hydralazine hydrochloride depicting its molecular framework with aromatic and hydrazine groups, accompanied by HCl indicating the hydrochloride salt form.*
FDA Label Image

Figure 1 (Isosorbide 03)

Figure 1 (Isosorbide 03)
A Kaplan-Meier plot showing time to death by all causes in Black patients (A-HeFT study). The graph compares survival percent over time (days) for two groups: BiDil and placebo, illustrating a 43% reduction in mortality for the BiDil group. Statistical significance is noted with a P value of 0.012 from a log-rank test.*
FDA Label Image

Figure 2 (Isosorbide 04)

Figure 2 (Isosorbide 04)
Kaplan-Meier plot showing time to first hospitalization for heart failure in Black patients with heart failure with reduced ejection fraction (A-HeFT). The graph compares BiDil versus placebo over approximately 600 days, depicting a higher percent without hospitalization for BiDil and noting a 39% risk reduction with BiDil. Statistical significance is reported with P <0.001 by Log-Rank test.*
FDA Label Image

Figure 3 (Isosorbide 05)

Figure 3 (Isosorbide 05)
This bar graph illustrates the change in Minnesota Living With Heart Failure Score over time, comparing BiDil and placebo groups at intervals from 3 to 18 months and at the study endpoint. It shows mean score changes with error bars, indicating greater improvement in the BiDil group, with statistical significance noted at two time points.*
FDA Label Image

Figure 4 (Isosorbide 06)

Figure 4 (Isosorbide 06)
A forest plot figure showing results for demographic, baseline medication, and clinical characteristic subgroups in Black patients from the A-HeFT study. It presents relative risk and 95% confidence intervals for all-cause mortality and first hospitalization for heart failure, comparing BiDil versus placebo across various patient subgroups.*
FDA Label Image

Principal Display Panel (90 Tablet Bottle Label)

Principal Display Panel (90 Tablet Bottle Label)
Label for Isosorbide Dinitrate and Hydralazine HCl tablets, film-coated, oral dosage form, strength 20 mg/37.5 mg. The label states a package size of 90 tablets and is labeled by Wilshire Pharmaceuticals. Storage instructions indicate room temperature between 15°C to 30°C (59°F to 86°F). The NDC on the label is 52536-006-09.*

* 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.