Sacu-structure-a (Sacu Structure A)
Sacubitril And Valsartan Tablet, Film Coated
Product Images NDC 67877-708
16 FDA label images from Ascend Laboratories, Llc · Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 67877-708). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Ascend Laboratories, 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.
Product Images & Figures Index
Sacu-figure1 (Sacu Figure1)
A chart showing the geometric mean ratio and 90% confidence interval for AUC and Cmax of various coadministered drugs including Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amlodipine, HCTZ, Metformin, Atorvastatin, and Sildenafil, with change relative to a reference on the x-axis.*
Sacu-figure2 (Sacu Figure2)
A comparative forest plot showing the geometric mean ratio and 90% confidence intervals for AUC and Cmax of LBQ657 and Valsartan in various population subgroups. The chart includes data on renal impairment (mild to severe), hepatic impairment (mild to moderate), age groups, gender, and race, illustrating pharmacokinetic changes relative to reference values.*
Sacu-fig-a-1 (Sacu Fig A 1)
A Kaplan-Meier cumulative failure rate graph showing time to first occurrence of cardiovascular death or heart failure hospitalizations comparing Sacubitril and Valsartan versus Enalapril in the PARADIGM-HF study. The x-axis represents time since randomization in days up to 1,260 days, and the y-axis shows cumulative failure rate as a percentage. The graph includes risk table data for both treatments over time.*
Sacu-fig-b-1 (Sacu Fig B 1)
A Kaplan-Meier curve chart showing the time to occurrence of cardiovascular (CV) death in the PARADIGM-HF study. The x-axis represents time since randomization (days), and the y-axis shows the cumulative failure rate percentage. Two lines compare Enalapril and Sacubitril and Valsartan, with Sacubitril and Valsartan demonstrating a lower failure rate over time. The hazard ratio with 95% confidence interval is 0.80 (0.71, 0.89). A table below the chart lists the number of patients at risk for each treatment group over time.*
Sacu-fig-c-2 (Sacu Fig C 2)
A line chart titled 'Time to First Occurrence of Heart Failure Hospitalizations in PARADIGM-HF', showing cumulative failure rate (%) over time in days since randomization. It compares two treatments, Sacubitril and Valsartan versus Enalapril, with Sacubitril and Valsartan showing a lower cumulative failure rate. The chart includes hazard ratio data and the number of patients at risk at various time points for both groups.*
Sacu-figure-4-c (Sacu Figure 4 C)
A forest plot chart comparing hazard ratios with 95% confidence intervals for Sacubitril and Valsartan versus Enalapril across various subgroups, including age, gender, weight, race, region, NYHA class, kidney function, diabetes, blood pressure, ejection fraction, atrial fibrillation, NT-proBNP levels, hypertension, prior medication use, heart failure history, cause of heart failure, and device presence. The x-axis ranges from 0.25 to 4, indicating relative effect favoring either Sacubitril and Valsartan or Enalapril.*
Sacu-figure5-a (Sacu Figure5 A)
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, and the y-axis shows the mean number of events per 100 patients. Two lines represent treatment groups: Valsartan (higher line) and Sacubitril and Valsartan (lower line), with event counts increasing over time and Sacubitril and Valsartan showing fewer events.*
Sacu-figure6-a (Sacu Figure6 A)
A forest plot graph comparing the rate ratios of Sacubitril and Valsartan versus Valsartan across various subgroups including age, gender, race, region, diabetes status, left ventricular ejection fraction (LVEF), atrial fibrillation history, NT proBNP level, systolic blood pressure, mineralocorticoid receptor antagonist (MRA) use, ACE inhibitor intolerance, baseline kidney function, and NYHA class. The plot shows estimates with 95% confidence intervals to indicate which treatment is better within each subgroup.*
Sacu-figure7 (Sacu Figure7)
This image contains two line graphs comparing hazard ratios with 95% confidence intervals. The left graph, labeled PARADIGM-HF, compares Sacubitril and Valsartan versus enalapril with hazard ratio on the y-axis and left ventricular ejection fraction at screening (%) on the x-axis. The right graph, labeled PARAGON-HF, compares Sacubitril and Valsartan versus valsartan, showing similar axes and trends.*
Sacu-val-24-26-60tab-a (Sacu Val 24 26 60tab A)
Label for Sacubitril and Valsartan Tablets 24 mg/26 mg film-coated tablets. The label indicates a package size of 60 tablets and includes storage instructions, manufacturer Alkem Laboratories Ltd., Mumbai, India, and distributor Ascend Laboratories, LLC. Additional label space is marked as unvarnished for UV varnishing and contains barcodes and regulatory codes.*
Sacu-val-24-26-180tab-a (Sacu Val 24 26 180tab A)
Label for Sacubitril and Valsartan Tablets 24 mg/26 mg film-coated tablets. The label includes dosage information, storage instructions, manufacturer Alkem Laboratories Ltd., distributor Ascend Laboratories, LLC, and a barcode. The package contains 180 tablets for oral use and is marked Rx Only.*
Sacu-val-49-51-60tab-a (Sacu Val 49 51 60tab A)
Sacubitril and Valsartan Tablets 49 mg/51 mg film-coated tablets package label from Ascend Laboratories, LLC. The label states the product contains 60 tablets and is Rx only. It includes storage instructions, manufacturers information, an NDC code, and barcodes. The label is primarily white with purple and red accents.*
Sacu-val-49-51-180tab-a (Sacu Val 49 51 180tab A)
Label for Sacubitril and Valsartan Tablets 49 mg/51 mg film-coated tablets. Contains 180 tablets per bottle. Manufactured by Alkem Laboratories, Ltd., India, and distributed by Ascend Laboratories, LLC. Label includes dosage information, storage instructions, and a barcode. Proprietary and nonproprietary name, strength, and quantity are prominent.*
Sacu-val-97-103-60tab-a (Sacu Val 97 103 60tab A)
Sacubitril and Valsartan Tablets label with strengths of 97 mg and 103 mg. The label indicates the product contains 60 film-coated oral tablets. It includes storage instructions, dosage reference, manufacturer Alkem Laboratories Ltd. (Mumbai, India), and distributor Ascend Laboratories, LLC (Parsippany, NJ). The label has a barcode and the Ascend Laboratories logo.*
Sacu-val-97-103-180tab-a (Sacu Val 97 103 180tab A)
Packaging label for Sacubitril and Valsartan Tablets, 97 mg/103 mg strength, film-coated oral tablets. The label indicates 180 tablets per container and displays the NDC 67877-709-51. It is distributed by Ascend Laboratories, LLC, with manufacturing by Alkem Laboratories Ltd., Mumbai, India. Storage instructions and a barcode are also shown.*
* 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.
