Sacubitril And Valsartan Tablet
Product Images NDC 71610-983

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 71610-983). 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 0983 89)

Label for Sacubitril and Valsartan oral tablets, strength 24 mg/26 mg, showing packaging for 720 tablets. The label includes manufacturer information for Evaric Pharmaceuticals Inc. and repackager Aphena Pharma Solutions - Tennessee, LLC, along with storage instructions and regulatory details.*

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Aphena (Aphena)

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545 (Sacubitril Valsartan Fig 1)

A forest plot chart depicting the geometric mean ratio and 90% confidence intervals for the pharmacokinetic parameters AUC and Cmax of various coadministered drugs relative to a reference. The drugs listed are Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amlodipine, HCTZ, Metformin, Atorvastatin, and Sildenafil, showing changes on a scale from 0.5 to 2 relative to the reference.*

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665 (Sacubitril Valsartan Fig 2)

A comparative forest plot showing geometric mean ratios and 90% confidence intervals for AUC and Cmax of LB0657 and Valsartan. The chart evaluates pharmacokinetic changes in different populations categorized by renal impairment, hepatic impairment, age, sex, and race, with changes relative to reference values.*

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898 (Sacubitril Valsartan Fig 3a)

A Kaplan-Meier curve showing time to first occurrence of cardiovascular death or heart failure hospitalizations in the PARADIGM-HF study. The graph compares Sacubitril and Valsartan versus Enalapril, plotting cumulative failure rate (%) over time in days since randomization. The graph includes number at risk data for both treatment groups at various time points and displays a hazard ratio (HR 0.80, 95% CI 0.73-0.87) with p-value <0.0001.*

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212 (Sacubitril Valsartan Fig 3b)

A Kaplan-Meier curve showing the time to occurrence of cardiovascular (CV) death in the PARADIGM-HF study comparing Sacubitril and Valsartan versus Enalapril. The x-axis represents time since randomization in days up to 1,260 days, and the y-axis shows the cumulative failure rate percentage. The graph indicates a lower cumulative failure rate for Sacubitril and Valsartan with a hazard ratio (HR) of 0.80 (95% CI: 0.71, 0.89). Participant numbers at risk for each treatment are shown below the x-axis at multiple time points.*

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554 (Sacubitril Valsartan Fig 3c)

A Kaplan-Meier curve showing 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 groups, with a hazard ratio (HR) of 0.79 (95% CI: 0.71, 0.89). Number at risk is indicated for each group at multiple time points.*

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565 (Sacubitril Valsartan Fig 4)

A forest plot chart comparing Sacubitril and Valsartan versus Enalapril across various subgroups, including age, gender, weight, race, region, NYHA class, estimated GFR, diabetes status, systolic blood pressure, ejection fraction, atrial fibrillation, NT-proBNP level, hypertension, prior medication use, hospitalization history, and heart failure cause. The plot shows hazard ratios with 95% confidence intervals for each subgroup along a scale indicating whether Sacubitril and Valsartan or Enalapril is favored.*

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989 (Sacubitril Valsartan Fig 5)

A line graph showing the mean number of heart failure hospitalization and cardiovascular death events per 100 patients over time since randomization (days) in the PARAGON-HF study. Two lines represent patients treated with Sacubitril and Valsartan versus Valsartan alone, with event numbers increasing over approximately 1440 days. A risk table below indicates the number of patients at risk at different time points.*

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565 (Sacubitril Valsartan Fig 6)

A forest plot comparing the rate ratios of Sacubitril and Valsartan versus Valsartan across various subgroups based on factors such as age, gender, race, region, diabetic status, LVEF, atrial fibrillation, NT-proBNP levels, blood pressure, ACEI intolerance, eGFR, and NYHA class. The plot visually represents the estimated rate ratios with 95% confidence intervals, illustrating relative effectiveness across these subgroups.*

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656 (Sacubitril Valsartan Fig 7)

A two-panel figure showing hazard ratio plots comparing Sacubitril and Valsartan to enalapril (left panel) and to valsartan (right panel) as a function of left ventricular ejection fraction at screening (%). Each graph includes a solid line for hazard ratio and dashed lines representing 95% confidence intervals.*

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565 (Sacubitril Valsartan Structure)

Chemical structure diagram of the active ingredients Sacubitril and Valsartan as depicted in the product image.*

* 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.