Sacubitril And Valsartan Tablet, Film Coated
Product Images NDC 0904-7580

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 0904-7580). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Major Pharmaceuticals, 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

Carton Label Of 30 Tablets (Sacu 24 26 30)

Sacubitril and Valsartan 24 mg/26 mg film-coated tablets packaging label from Major Pharmaceuticals. The package contains 30 tablets (3 x 10), labeled as Rx Only with NDC 0904-7580-04. Manufactured by Alkem Laboratories Ltd., India, and distributed by Major Pharmaceuticals, USA. Storage instructions and dosage details are partially visible.*

FDA Label Image

Carton Label Of 30 Tablets (Sacu 49 51 30)

Packaging label for Sacubitril and Valsartan Tablets, 49 mg/51 mg strength, by Major Pharmaceuticals. The label is for a unit dose package containing 30 film-coated tablets (3x10). It includes dosing details, storage instructions, and manufacturer information from Alkem Laboratories Ltd., India, and distributor details from Major Pharmaceuticals, Indianapolis, USA.*

FDA Label Image

Sacu-97-103-30-a (Sacu 97 103 30 A)

Sacubitril and Valsartan 97 mg/103 mg film-coated tablets packaging label. The label shows a box containing 30 tablets (3 x 10) for oral use, labeled for prescription only (Rx Only). The product is distributed by Major Pharmaceuticals and manufactured by Alkem Laboratories Ltd., Mumbai, India. The label includes storage instructions and barcodes, and the NDC number 0904-7581-04 is printed.*

FDA Label Image

Sacu-fig-a-1 (Sacu Fig A 1)

A Kaplan-Meier curve displaying time to first occurrence of cardiovascular death or heart failure hospitalizations in the PARADIGM-HF study. The graph compares Sacubitril and Valsartan with Enalapril over approximately 1,260 days, showing cumulative failure rates (%) on the y-axis and time since randomization (days) on the x-axis. A risk table at the bottom lists patient counts over time for each treatment group.*

FDA Label Image

Sacu-fig-b-1 (Sacu Fig B 1)

A Kaplan-Meier curve titled 'Time to Occurrence of CV Death in PARADIGM-HF' comparing cumulative failure rates (%) over time (days) between Sacubitril and Valsartan versus Enalapril. The graph shows a lower failure rate for Sacubitril and Valsartan across approximately 1,260 days with a hazard ratio of 0.80 (95% CI: 0.71, 0.89). The number of patients at risk is noted below the x-axis.*

FDA Label Image

Sacu-fig-c-2 (Sacu Fig C 2)

A Kaplan-Meier curve chart titled 'Time to First Occurrence of Heart Failure Hospitalizations in PARADIGM-HF'. It shows the cumulative failure rate percentage over time since randomization (days) for Sacubitril and Valsartan versus Enalapril. The chart includes a hazard ratio with confidence interval and lists the number of patients at risk for both treatments at various time points up to 1,260 days.*

FDA Label Image

Sacu-figure-4-c (Sacu Figure 4 C)

This is a forest plot comparing Sacubitril and Valsartan versus Enalapril across various patient subgroups. It displays subgroup percentages of the total population, event counts and percentages for each drug, and corresponding hazard ratios with 95% confidence intervals. The horizontal axis indicates relative effect, with Sacubitril and Valsartan favored to the left and Enalapril to the right.*

FDA Label Image

Sacu-figure1 (Sacu Figure1)

A scatter plot showing the geometric mean ratio and 90% confidence intervals for the area under the curve (AUC) and maximum concentration (Cmax) of various coadministered drugs, including Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amlodipine, HCTZ, Metformin, Atorvastatin, and Sildenafil, relative to a reference value of 1. Black circles represent AUC and white circles represent Cmax.*

FDA Label Image

Sacu-figure2 (Sacu Figure2)

A forest plot chart showing geometric mean ratios and 90% confidence intervals for AUC and Cmax comparing LBQ657 and Valsartan across different population subgroups, including renal impairment levels, hepatic impairment, age groups, gender, and ethnicity.*

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Sacu-figure5-a (Sacu Figure5 A)

A line graph comparing mean number of total heart failure hospitalizations and cardiovascular death events per 100 patients over time in days since randomization in the PARAGON-HF study. Two lines show event rates for Valsartan and Sacubitril and Valsartan, with Sacubitril and Valsartan consistently lower. The graph includes numbers at risk for each treatment group over time.*

FDA Label Image

Sacu-figure6-a (Sacu Figure6 A)

A forest plot comparing the rate ratios with 95% confidence intervals for Sacubitril and Valsartan versus Valsartan across various subgroups including age, gender, race, region, diabetes status, LVEF, atrial fibrillation history, NT proBNP levels, systolic blood pressure, MRA use, ACEI intolerance, baseline eGFR, and NYHA class. The plot includes point estimates and confidence intervals illustrating relative efficacy between the two treatments.*

FDA Label Image

Sacu-figure7 (Sacu Figure7)

This chart compares the hazard ratios of Sacubitril and Valsartan versus enalapril and versus valsartan in two studies, PARADIGM-HF and PARAGON-HF, respectively. The x-axis represents the left ventricular ejection fraction at screening (%), while the y-axis shows the hazard ratio with 95% confidence intervals indicated by dashed lines around a solid hazard ratio line.*

FDA Label Image

Structure (Sacu Structure)

Chemical structure diagram of sacubitril and valsartan showing detailed molecular bonds and components as presented in the product's FDA labeling.*

* 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.