Sacubitril And Valsartan Tablet, Film Coated
Product Images NDC 70377-032

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 70377-032). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biocon Pharma Inc., 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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Sacubitril And Valsartan Tablets 24 mg/26 mg, 500's Tablets (24 26mg 500s)

This is a description for Sacubitril and Valsartan Tablets 24 mg/26 mg. Each film-coated tablet contains 24 mg of sacubitrl and 26 mg of valsartan. It is recommended to store between 20°C to 25°C (68°F to 77°F). Keep the tablets protected from moisture, out of reach of children, and in a tight container with a child-resistant closure. The tablets are manufactured by Biocon Pharma Limited in Bengaluru, India, and manufactured for Biocon Pharma Inc in Iselin, NJ, USA. Dosage instructions are to refer to the prescribing information.*

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Sacubitril And Valsartan Tablets 24 mg/26 mg, 60's Tablets (24 26mg 60s)

This is a description of a film-coated tablet containing 24 mg of sacubitril and 26 mg of valsartan. The usual dosage information is provided in the prescribing information. The medication is manufactured by Biocon Pharma Limited in Bengaluru, India, for Biocon Pharma Inc in Iselin, New Jersey, USA. Storage instructions include keeping it between 15°C to 30°C and protecting it from moisture. It is important to keep this medication out of the reach of children.*

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Sacubitril And Valsartan Tablets 49 mg/51 mg, 500's Tablets (49 51 500s)

This is a description of a medication containing 49 mg of sacubitril and 51 mg of valsartan per film-coated tablet. The usual dosage is to be determined as per prescribing information. The tablets should be stored at a temperature between 20°C to 25°C, with excursions permitted between 15°C to 30°C. It is important to protect the medication from moisture and keep it out of the reach of children. The tablets are to be stored in a tight container with a child-resistant closure. The medication is manufactured by Biocon Pharma Limited in Bengaluru, India, and this information is intended for prescription-only use.*

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Sacubitril And Valsartan Tablets 49 mg/51 mg, 60's Tablets (49 51 60s)

This is a description of a medication labeled as sacubitril and valsartan tablets with a dosage of 49 mg/51 mg. The tablets are film-coated and come in a pack of 60. The usual dosage instructions are mentioned in the prescribing information. The medication should be stored at temperatures between 20°C to 25°C, with excursions allowed between 15°C to 30°C. It should be protected from moisture and kept out of the reach of children. The tablets are manufactured by Biocon Pharma Limited in Bengaluru, India, for Biocon Pharma Inc in Iselin, NJ, USA. The manufacturing license number is KTK/25/664/2017.*

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Sacubitril And Valsartan Tablets 97 mg/103 mg, 500's Tablets (97 103mg 500s)

This is a description of Sacubitril and Valsartan Tablets packaged in a container of 500 tablets. Each film-coated tablet contains 97 mg of sacubitril and 103 mg of valsartan. The recommended storage conditions are at 20°C to 25°C, with excursions permitted from 15°C to 30°C. It is important to protect the tablets from moisture and keep them out of the reach of children. The tablets are dispensed in a tight, resistant closure in a container with two child-resistant closures. The manufacturer is Biocon Pharma Limited in Bengaluru, India, and it is manufactured for Biocon Pharma Inc in Iselin, NJ, USA. The package size is 72x47 mm.*

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Sacubitril And Valsartan Tablets 97 mg/103 mg, 60's Tablets (97 103mg 60s)

This is information about Sacubitril and Valsartan Tablets, which each contain 97 mg of sacubitril and 103 mg of valsartan. The prescription dosage should be followed as per the prescribing information. The tablets should be stored at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). The manufacturer is Biocon Pharma Limited located in Bengaluru, India, and manufactured for Biocon Pharma Inc in Iselin, NJ, USA. It is important to keep this medication and all drugs out of the reach of children.*

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Figure 1: Effect Of Sacubitril And Valsartan Tablets On Pharmacokinetics Of Coadministered Drugs (Figure 1)

This is a list of coadministered drugs with their geometric mean ratio and 90% CI values. The drugs include Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amlodipine, HCTZ, Metformin, Atorvastatin, and Sildenafil. The table also indicates the change relative to the reference drug.*

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Figure 3: Kaplan-meier Curves For The Primary Composite Endpoint (a), Cardiovascular Death (b), And Heart Failure Hospitalization (c) (Image A)

This text provides data on the time to the first occurrence of cardiovascular death or heart failure hospitalizations in the PARADIGM-HF study. It includes statistical information with hazard ratios and confidence intervals. The graph represents the number of patients at risk over time since randomization in days, comparing the outcomes for patients treated with Sacubitril and Valsartan Tablets versus Enalapril.*

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Image-b (Image B)

This text provides information on the time to occurrence of cardiovascular death (CV death) in the PARADIGM-HF study. The study compares the outcomes of patients receiving Enalapril with those receiving Sacubitel and Valsartan tablets. The graph shows the Hazard Ratio (HR) of 0.80 with a confidence interval of 95% (0.71, 0.89) for Sacubitel and Valsartan compared to Enalapril. The x-axis represents time since randomization in days, and the y-axis shows the number of CV death occurrences over time.*

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Image-c (Image C)

This is a description of a clinical study involving heart failure patients treated with Sacubitrl and Valsartan Tablets compared to Enalapril. It shows the time to the first occurrence of heart failure hospitalizations and includes hazard ratio (HR) values. The table provides Kaplan-Meier estimates of cumulative failure rates over a period of time since randomization in days, with the number of patients at risk indicated at different time points.*

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Image-d (Image D)

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Figure-6 (Fig 6)

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Figure-7 (Fig 7)

This text appears to list the names of different drug combinations being compared in tables related to left ventricular ejection fraction in a medical study. The comparison is between sacubitril and valsartan versus enalapril, and sacubitril and valsartan versus valsartan. The study may be related to heart failure treatment evaluation.*

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Figure 2: Pharmacokinetics Of Sacubitril And Valsartan Tablets In Specific Populations (Figure 2)

This appears to be a table showing the Geometric Mean Ratio and 90% Confidence Intervals for different populations and conditions in relation to reference values. The table includes comparisons for renal impairment (mild, moderate, severe), hepatic impairment (mild, moderate), age groups, gender (male/female), and different races (Asian, Caucasian, Black). The table seems to display changes relative to a reference point, providing data on the impact of various factors on the population under study.*

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Figure 5: Mean Number Of Events Over Time For The Primary Composite Endpoint Of Total Hf Hospitalizations And Cv Death (Figure 5)

The text provides data on the mean number of events per 100 patients in a study related to Heart Failure Hospitalizations and Cardiovascular Death in the PARAGON-HF trial involving Sacubitril and Valsartan Tablets. The data seems to represent a timeline from 0 to 1440 days since randomization, with specific numbers given at various intervals.*

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Sacubitril Sodium (Sacubitril Sodium)

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Valsartan Disodium (Valsartan Disodium)

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