Sacubitril And Valsartan Tablet, Film Coated
Product Images NDC 43598-645

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 43598-645). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dr. Reddy's Laboratories 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.

FDA Label Image

Container1 (Container1)

Label for Sacubitril and Valsartan Tablets 24 mg/26 mg film-coated tablets by Dr. Reddy's Laboratories Inc. The label shows prescription only status, NDC 43598-643-60, and package quantity of 60 tablets. Storage instructions, distributor information, barcode, and manufacturing details are also visible.*

FDA Label Image

Container2 (Container2)

Packaging label for Sacubitril and Valsartan Tablets 49 mg/51 mg, film-coated oral tablets. The label shows a quantity of 60 tablets and is distributed by Dr. Reddy's Laboratories Inc. It includes storage instructions and a barcode, with a prominent display of the dosage strength and product name.*

FDA Label Image

Container3 (Container3)

Label for Sacubitril and Valsartan Tablets 97 mg/103 mg, film-coated oral tablets. The label indicates a package of 60 tablets, with storage instructions and manufacturer information for Dr. Reddy's Laboratories Inc. It includes NDC 43598-645-60 and barcode details.*

FDA Label Image

Figure1 (Figure1)

A scatter plot chart showing the geometric mean ratio and 90% confidence intervals for coadministered drugs including Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amlodipine, HCTZ, Metformin, Atorvastatin, and Sildenafil. Data points represent AUC and Cmax changes relative to reference values.*

FDA Label Image

Figure2 (Figure2)

A forest plot displaying the geometric mean ratios and 90% confidence intervals for AUC and Cmax of LBQ657 and Valsartan across various population subgroups, including different levels of renal and hepatic impairment, age, sex, and race. The x-axis represents change relative to reference on a logarithmic scale from 0.5 to 4.*

FDA Label Image

Figure3 (Figure3)

Three Kaplan-Meier plots labeled Figure A, B, and C show time-to-event curves for comparisons between Sacubitril and Valsartan versus Enalapril in the PARADIGM-HF study. Figure A illustrates time to first occurrence of cardiovascular death or heart failure hospitalizations. Figure B shows time to cardiovascular death, and Figure C shows time to heart failure hospitalizations. Each graph includes hazard ratios and confidence intervals, time since randomization in days on the x-axis, and cumulative failure rate percentage on the y-axis.*

FDA Label Image

Figure4 (Figure4)

A forest plot chart showing hazard ratios with 95% confidence intervals comparing Sacubitril and Valsartan versus Enalapril across multiple patient subgroups. The x-axis ranges from 0.25 (Sacubitril and Valsartan better) to 4 (Enalapril better). Subgroups include age, gender, weight, race, region, NYHA class, eGFR, diabetes status, blood pressure, ejection fraction, atrial fibrillation, NT-proBNP levels, hypertension, prior medication use, heart failure history, time since diagnosis, cause of heart failure, and ICD presence. Each subgroup displays the percentage of total population, event rates for both drugs, and hazard ratio markers on the plot.*

FDA Label Image

Figure5 (Figure5)

A line graph depicting total heart failure hospitalizations and cardiovascular death over time in the PARAGON-HF study. The x-axis shows time since randomization in days (0 to 1440), and the y-axis shows the mean number of events per 100 patients (0 to 60). Two lines compare treatments: one for Valsartan (gray) and one for Sacubitril and Valsartan (black), with the Sacubitril and Valsartan line consistently lower, indicating fewer events. Patient counts at risk are listed over time below the graph for both treatment groups.*

FDA Label Image

Figure6 (Figure6)

A forest plot chart comparing rate ratios of Sacubitril and Valsartan versus Valsartan across various subgroups, including age, gender, race, region, diabetic status, and other clinical parameters. The plot displays point estimates with 95% confidence intervals for each subgroup to indicate relative treatment effect.*

FDA Label Image

Figure7 (Figure7)

A dual-panel line chart titled PARADIGM-HF and PARAGON-HF comparing Sacubitril and Valsartan versus enalapril and valsartan respectively. The y-axis represents Hazard Ratio with values from 0.5 to 1.6, and the x-axis shows Left Ventricular Ejection Fraction at screening (%) ranging approximately from 15 to 75. Each panel includes a solid line for Hazard Ratio and dashed lines indicating 95% confidence intervals.*

FDA Label Image

Structure (Structure)

Chemical structure diagram of sacubitril and valsartan, showing the detailed molecular framework including sodium ions and water of hydration associated with the compound.*

* 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.