Sacubitril And Valsartan Tablet, Film Coated
Product Images NDC 67877-950

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 67877-950). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ascend Laboratories, Llc, 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

97 mg/103 mg 180 Tablets Lablel (Sacu 97 103 180 1)

Label for Sacubitril and Valsartan Tablets, 97 mg/103 mg film-coated oral tablets by Ascend Laboratories, LLC. The label states each tablet contains 97 mg sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg valsartan equivalent to 113.2 mg valsartan disodium. The package includes 180 tablets and provides storage instructions and manufacturer/distributor information.*

FDA Label Image

Sacu-fig-a-1 (Sacu Fig A 1)

A Kaplan-Meier curve comparing the time to first occurrence of cardiovascular death or heart failure hospitalizations in the PARADIGM-HF trial between Sacubitril and Valsartan and Enalapril over approximately 1,260 days. The graph shows cumulative failure rates with Sacubitril and Valsartan resulting in a lower rate compared to Enalapril. The number of subjects at risk is presented below the time axis.*

FDA Label Image

Sacu-fig-b-1 (Sacu Fig B 1)

A Kaplan-Meier curve showing the time to occurrence of cardiovascular (CV) death in the PARADIGM-HF study. The graph compares cumulative failure rates (%) over time in days since randomization for Sacubitril and Valsartan versus Enalapril. Sacubitril and Valsartan shows a lower failure rate than Enalapril. Risk numbers at various time points are provided below the x-axis.*

FDA Label Image

Sacu-fig-c-2 (Sacu Fig C 2)

A Kaplan-Meier curve chart illustrating cumulative failure rate (%) over time (days) since randomization for heart failure hospitalizations in the PARADIGM-HF study. The chart compares Sacubitril and Valsartan with Enalapril, showing the time to first occurrence of hospitalization. Risk numbers at various time points are shown beneath the x-axis, with a hazard ratio (HR) and confidence interval noted on the graph.*

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Sacu-figure-4-c (Sacu Figure 4 C)

A forest plot comparing the hazard ratios with 95% confidence intervals for Sacubitril and Valsartan versus Enalapril across multiple subgroups. Subgroups include age, gender, weight, race, region, NYHA class, estimated GFR, diabetes status, systolic blood pressure, ejection fraction, atrial fibrillation, NT-proBNP levels, hypertension, prior use of ACE inhibitors or ARBs, prior hospitalization for heart failure, time since diagnosis, cause of heart failure, and presence of ICD devices. The x-axis labels indicate whether Sacubitril and Valsartan or Enalapril is favored.*

FDA Label Image

Sacu-figure1 (Sacu Figure1)

A scatter plot chart displaying geometric mean ratios and 90% confidence intervals for various coadministered drugs compared to a reference. The chart plots drugs on the vertical axis and relative change on the horizontal axis, with data points for AUC and Cmax shown as filled and open circles respectively, illustrating pharmacokinetic interaction metrics.*

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Sacu-figure2 (Sacu Figure2)

A comparative dot plot chart showing the geometric mean ratios and 90% confidence intervals of AUC and Cmax values for Sacubitril and Valsartan (LBQ657 and Valsartan) across different populations. Populations include varying renal and hepatic impairments, age groups, sex, and racial groups, with changes relative to reference indicated on logarithmic scales on both axes.*

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Sacu-figure5-a (Sacu Figure5 A)

Line graph showing total heart failure hospitalizations and cardiovascular death over time in the PARAGON-HF trial. The x-axis represents time since randomization in days, and the y-axis shows the mean number of events per 100 patients. Two lines compare Valsartan and Sacubitril and Valsartan, with Sacubitril and Valsartan showing fewer events over time. A table below indicates number of patients at risk at various time points for both groups.*

FDA Label Image

Sacu-figure6-a (Sacu Figure6 A)

A forest plot comparing Sacubitril and Valsartan versus Valsartan alone across various subgroups including age, gender, race, region, diabetes status, LVEF, atrial fibrillation, NT proBNP levels, systolic blood pressure, MRA use, ACEI intolerance, baseline eGFR, and NYHA classification. The plot shows rate ratios with 95% confidence intervals, visually indicating which treatment performs better within each subgroup.*

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Sacu-figure7 (Sacu Figure7)

This figure includes two line graphs comparing hazard ratios for sacubitril and valsartan against enalapril and valsartan, respectively. The x-axes represent left ventricular ejection fraction at screening (%) from 15 to 75, and the y-axes display hazard ratios ranging approximately from 0.5 to 1.6. Each graph shows a solid line for hazard ratio and dashed lines for 95% confidence intervals.*

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Structure (Sacu Structure)

Chemical structure of the active ingredients Sacubitril and Valsartan, showing the molecular arrangement of atoms and bonds supplying detailed structural information for these compounds.*

FDA Label Image

49 mg/51 mg 60 Tablets Label (Sacu Val 49 51 60tab A)

Label for Sacubitril and Valsartan Tablets, 49 mg/51 mg film-coated tablets, oral use. The label indicates 60 tablets per bottle, manufactured by Alkem Laboratories Ltd and distributed by Ascend Laboratories, LLC. The label includes dosing information, storage instructions, and a barcode.*

* 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.