Sacubitril And Valsartan Tablet
Product Images NDC 71610-982

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 71610-982). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Label (71610 0982 89)

Label for Sacubitril and Valsartan tablets, 49 mg/51 mg strength, containing 720 tablets. Includes storage instructions, manufacturer Evraic Pharmaceuticals Inc. in Hauppauge, NY, and repackager Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. Displays the NDC number 71610-982-89 and indicates the product is for prescription use only.*

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Aphena (Aphena)

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545 (Sacubitril Valsartan Fig 1)

This is a forest plot displaying the geometric mean ratios and 90% confidence intervals of pharmacokinetic parameters AUC and Cmax for various coadministered drugs compared to reference values. Drugs listed include Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amlodipine, HCTZ, Metformin, Atorvastatin, and Sildenafil. Data points with confidence intervals indicate changes relative to reference values on a horizontal axis ranging approximately from 0.5 to 2.*

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665 (Sacubitril Valsartan Fig 2)

A chart depicting the geometric mean ratio and 90% confidence interval (CI) for AUC and Cmax comparing populations with various renal and hepatic impairments, age groups, sex, and race for two substances labeled LB0657 and Valsartan. The x-axis shows change relative to reference with values ranging from 0.5 to 4.*

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898 (Sacubitril Valsartan Fig 3a)

A Kaplan-Meier curve showing the time to first occurrence of cardiovascular death or heart failure hospitalizations in the PARADIGM-HF study comparing Sacubitril and Valsartan versus Enalapril over approximately 1,260 days. The graph plots cumulative failure rate (%) over time since randomization (days), with patient risk numbers at various time points. Sacubitril and Valsartan demonstrates a lower cumulative failure rate compared to Enalapril, with a hazard ratio of 0.80 (95% CI: 0.73, 0.87) and p-value <0.0001.*

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212 (Sacubitril Valsartan Fig 3b)

A Kaplan-Meier curve chart titled 'Time to Occurrence of CV Death in PARADIGM-HF' comparing cumulative failure rates (%) over time in days between Sacubitril and Valsartan versus Enalapril. It includes hazard ratio (HR 0.80 with 95% CI 0.71 to 0.89) and number at risk for both treatment groups at several time points up to 1260 days.*

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554 (Sacubitril Valsartan Fig 3c)

A Kaplan-Meier curve displaying the time to first occurrence of heart failure hospitalizations in the PARADIGM-HF study. The graph compares cumulative failure rates (%) over time (days) since randomization between Sacubitril and Valsartan and Enalapril, including the number of patients at risk at various time points and a hazard ratio (HR) with 95% confidence interval.*

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565 (Sacubitril Valsartan Fig 4)

A hazard ratio forest plot comparing Sacubitril and Valsartan versus Enalapril across various subgroups such as age, gender, weight, race, region, NYHA class, kidney function, diabetes status, blood pressure, ejection fraction, atrial fibrillation, NT-proBNP levels, hypertension, prior medication use, heart failure history, cause of heart failure, and ICD use. Each subgroup shows the percentage of the total population, event counts with percentages, and corresponding hazard ratios with confidence intervals plotted visually.*

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989 (Sacubitril Valsartan Fig 5)

A line graph comparing mean number of heart failure hospitalizations and cardiovascular (CV) deaths per 100 patients over time in days since randomization in the PARAGON-HF study. Two lines represent patient groups: one treated with valsartan alone and one with sacubitril and valsartan combination. The graph shows cumulative events increasing over approximately 1440 days, with sacubitril and valsartan consistently showing slightly fewer events. Below the graph, a table lists the number of patients at risk at various time points for both treatment groups.*

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565 (Sacubitril Valsartan Fig 6)

A subgroup analysis forest plot comparing the rate ratio of Sacubitril and Valsartan versus Valsartan across various demographic and clinical subgroups, including age, gender, race, geographic region, diabetic status, LVEF, atrial fibrillation, NT-proBNP levels, blood pressure, ACE inhibitor intolerance, renal function, and NYHA class. The plot presents point estimates with 95% confidence intervals for the rate ratio, illustrating relative treatment effects on a horizontal axis labeled from 0.25 to 2, indicating which drug is favored in each subgroup.*

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656 (Sacubitril Valsartan Fig 7)

A chart comparing hazard ratios with 95% confidence intervals in two studies: PARADIGM-HF (Sacubitril and valsartan vs. enalapril) and PARAGON-HF (Sacubitril and valsartan vs. valsartan). The x-axis represents left ventricular ejection fraction at screening (%), and the y-axis shows the hazard ratio. Each study's hazard ratios are plotted with solid lines and confidence intervals with dashed lines.*

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565 (Sacubitril Valsartan Structure)

Chemical structure diagram of Sacubitril and Valsartan, showing the molecular configurations of both active ingredients with detailed bond connectivity and stereochemistry.*

* 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.