Sacubitril And Valsartan Tablet
Product Images NDC 71610-984

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 71610-984). 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 0984 37)

Label for Sacubitril/Valsartan tablets with a strength of 97 mg/103 mg, containing 3120 tablets. The label includes the NDC number 71610-984-37 and storage instructions to keep between 20-25 degrees Celsius. Manufactured by Evaric Pharmaceuticals Inc. and repackaged by Aphena Pharma, Cookeville, TN. The label also features the batch number and expiration date fields.*

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Aphena (Aphena)

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545 (Sacubitril Valsartan Fig 1)

A forest plot chart titled 'Coadministered Drugs Geometric Mean Ratio and 90% CI' showing the effect of various drugs on AUC and Cmax relative to a reference value of 1. Drugs listed include Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amlodipine, HCTZ, Metformin, Atorvastatin, and Sildenafil. Data points for each drug display black circles for AUC and open circles for Cmax with 90% confidence intervals.*

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665 (Sacubitril Valsartan Fig 2)

A comparison chart depicting the geometric mean ratios and 90% confidence intervals of AUC and Cmax for Sacubitril and Valsartan across different populations. Variables include renal and hepatic impairment, age, sex, and race, showing changes relative to reference values.*

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898 (Sacubitril Valsartan Fig 3a)

A Kaplan-Meier plot showing the time to first occurrence of cardiovascular death or heart failure hospitalizations from the PARADIGM-HF study. The graph compares cumulative failure rates over days since randomization between Sacubitril and Valsartan and Enalapril, with Sacubitril and Valsartan showing a lower failure rate. The number of patients at risk is listed over time for both treatments.*

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212 (Sacubitril Valsartan Fig 3b)

A Kaplan-Meier curve graph showing the time to occurrence of cardiovascular (CV) death in the PARADIGM-HF study. The graph compares cumulative failure rates (%) over time since randomization (days) between Sacubitril and Valsartan and Enalapril, with a hazard ratio (HR) of 0.80 (95% CI: 0.71, 0.89). Numbers at risk for both treatments are provided at multiple time points up to 1,260 days.*

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554 (Sacubitril Valsartan Fig 3c)

A Kaplan-Meier curve chart titled 'Time to First Occurrence of Heart Failure Hospitalizations in PARADIGM-HF,' comparing cumulative failure rates of Sacubitril and Valsartan versus Enalapril over time since randomization (days). The chart includes hazard ratio data (HR 0.79; 95% CI 0.71 to 0.89) and a table of numbers at risk for each treatment group across the time points.*

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565 (Sacubitril Valsartan Fig 4)

A forest plot chart comparing the hazard ratios with 95% confidence intervals for various subgroups using Sacubitril and Valsartan versus Enalapril. The data covers subgroups based on age, gender, weight, race, region, NYHA class, eGFR levels, diabetes status, systolic blood pressure, ejection fraction, atrial fibrillation status, NT-proBNP levels, hypertension status, prior medication use, prior hospitalizations, time since heart failure diagnosis, cause of heart failure, and presence of ICD devices. The horizontal axis shows the hazard ratio scale where values less than 1 favor Sacubitril and Valsartan and values greater than 1 favor Enalapril.*

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989 (Sacubitril Valsartan Fig 5)

A line graph titled 'Time Heart Failure Hospitalization and CV Death in PARAGON-HF' comparing mean number of events per 100 patients over time since randomization (days) between valsartan alone and sacubitril and valsartan. The graph shows two lines with sacubitril and valsartan trending slightly lower than valsartan. Patient numbers at risk decrease over time and are listed below the graph.*

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565 (Sacubitril Valsartan Fig 6)

A forest plot chart comparing the rate ratios of Sacubitril and Valsartan versus Valsartan alone across various subgroups. The horizontal axis shows the rate ratio scale from 0.25 to 2.0, with data points and confidence intervals represented by squares and lines, respectively. Subgroups include age, gender, race, region, diabetic status, LVEF, atrial fibrillation, NT-proBNP levels, blood pressure, ACEI intolerance, baseline eGFR, and NYHA classification. The chart visually indicates the relative effectiveness of the two treatments across these categories.*

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656 (Sacubitril Valsartan Fig 7)

A dual line chart comparing hazard ratios with 95% confidence intervals between Sacubitril and Valsartan versus enalapril and versus valsartan. The horizontal axis represents left ventricular ejection fraction at screening (%), while the vertical axis shows the hazard ratio. Two panels labeled PARADIGM-HF and PARAGON-HF illustrate different comparative analyses for the active ingredients.*

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565 (Sacubitril Valsartan Structure)

Chemical structure diagram of Sacubitril and Valsartan, showing the molecular arrangement of the active ingredients in this prescription tablet.*

* 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.