Sacubitril And Valsartan Tablet, Film Coated
Product Images NDC 69238-2733

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 69238-2733). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Ny 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.

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Chem Structure (Sacubitril And Valsartan Tablets 1)

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Figure 7 (Sacubitril And Valsartan Tablets 10)

This description mentions two clinical trials related to heart failure medications: PARADIGM-HF comparing sacubitril and valsartan versus enalapril, and PARAGON-HF comparing sacubitril and valsartan versus valsartan. The text also includes a chart showing different left ventricular ejection fractions at screening.*

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24mg-26mg Label (Sacubitril And Valsartan Tablets 11)

This is a description of a medication called Sacubitril and Valsartan Tablets, with a dosage of 24 mg of sacubitril and 26 mg of valsartan per tablet. The usual dosage should be obtained from the prescribing information. It is advised to store the tablets between 20°C to 25°C (68°F to 77°F) with an allowed range of 15°C to 30°C (59°F to 86°F). The tablets should be protected from moisture and kept out of the reach of children. The medication is manufactured by Harman Finochem Limited in Ch. Sambhajinagar, Maharashtra, India, and distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ.*

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49mg-51mg Label (Sacubitril And Valsartan Tablets 12)

This is a description of Sacubitril and Valsartan tablets, with each film-coated tablet containing 49 mg of sacubitril and 51 mg of valsartan. The usual dosage instructions are advised to be seen in the prescribing information. It is recommended to store the tablets at a temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59'F to 86'F) and protect them from moisture. The medication should be kept out of reach of children. The tablets are manufactured by Harman Finochem Limited in Maharashtra, India, and distributed by Amneal Pharmaceuticals LLC in Bridgewater, New Jersey.*

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97mg-103mg Label (Sacubitril And Valsartan Tablets 13)

This text provides information on a medication called Sacubitril and Valsartan Tablets, containing 97 mg of sacubitril and 103 mg of valsartan per film-coated tablet. It is intended for prescription use with a usual dosage as per prescribing information. The storage temperature range is specified between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59 to 86°F). The medication should be protected from moisture and kept out of the reach of children. The manufacturing company is Harman Finochem Limited in India, and it is distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ.*

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Figure 1 (Sacubitril And Valsartan Tablets 2)

This is a list of coadministered drugs along with their geometric mean ratio and 90% confidence interval for the change relative to the reference. The list includes drugs such as Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amiodipine, HCTZ, Metformin, Atorvastatin, and Sildenafil.*

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Figure 2 (Sacubitril And Valsartan Tablets 3)

This is a population description including information about renal and hepatic impairments, age range, and geometric mean ratios with corresponding 90% confidence intervals. The text appears to be detailing data on different levels of renal and hepatic impairment alongside age groups in a study or analysis.*

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Figure 3a (Sacubitril And Valsartan Tablets 4)

This text seems to describe a study or trial named "PARADIGM-HF" that evaluates the time to the first occurrence of cardiovascular death or heart failure hospitalizations. The results indicate a statistically significant outcome with p<0.0001 and a Hazard Ratio (HR) of 0.80 (95% confidence interval: 0.73, 0.87). The text also includes a Kaplan-Meier estimate of the cumulative failure rate over time since randomization, comparing the outcomes between different groups or treatments named as "pacdirivabarss" and "Enalapril." These results suggest a potential benefit of the intervention in reducing the risk of cardiovascular events in the study participants.*

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Figure 3b (Sacubitril And Valsartan Tablets 5)

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Figure 3c (Sacubitril And Valsartan Tablets 6)

This text provides information about the Time to First Occurrence of Heart Failure Hospitalizations in PARADIGM-HF, including a graph showing the cumulative failure rate over time since randomization in days. The hazard ratio (HR) and 95% confidence interval (CI) are also included in the data. The text suggests that this information is based on a study involving the drug Enalapril.*

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Figure 4 (Sacubitril And Valsartan Tablets 7)

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Figure 5 (Sacubitril And Valsartan Tablets 8)

Not available.*

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Figure 6 (Sacubitril And Valsartan Tablets 9)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.