Sacubitril And Valsartan Tablet
Product Images NDC 71610-983

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 71610-983). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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.

FDA Label Image

Label (71610 0983 89)

Label (71610 0983 89)
This is a medication with the name Sacubitril/Valsartan, with a strength of 24mg/26mg. It has a GTIN number of 1037161083800 and an NDC number of 71610-983-89. The manufacturing lot number is S/N: Fodgeoze0s and the batch number is 2. The expiration date is indicated as "&4".*
FDA Label Image

Aphena (Aphena)

FDA Label Image

545 (Sacubitril Valsartan Fig 1)

545 (Sacubitril Valsartan Fig 1)
This is a list of coadministered drugs along with their geometric mean ratio and 90% confidence interval. The drugs included in the list are Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amlodipine, HCTZ, Metformin, Atorvastatin, and Sildenafil. The table also mentions "Change relative to reference."*
FDA Label Image

665 (Sacubitril Valsartan Fig 2)

FDA Label Image

898 (Sacubitril Valsartan Fig 3a)

898 (Sacubitril Valsartan Fig 3a)
This text provides data on the time to first occurrence of cardiovascular death or heart failure hospitalizations in the PARADIGM-HF study, comparing the outcomes between sacubitril and valsartan versus enalapril. The results indicate a statistically significant improvement in the outcome for the sacubitril and valsartan group with a p-value of less than 0.0001. The hazard ratio with a 95% confidence interval was 0.80 (0.73, 0.87), suggesting a reduced risk with sacubitril and valsartan treatment. Additionally, the failure rate over time is shown for both treatment groups, displaying the number at risk and time since randomization in days.*
FDA Label Image

212 (Sacubitril Valsartan Fig 3b)

212 (Sacubitril Valsartan Fig 3b)
This text provides data on the Time to Occurrence of Cardiovascular (CV) Death in the PARADIGM-HF study. The hazard ratio (HR) with a 95% confidence interval is shown as 0.80 (0.71, 0.89) for Sacubitril and Valsartan compared to Enalapril. The table further illustrates the failure rate (%) over time for both treatment groups, displaying the number at risk and time since randomization in days. This data could be used to analyze the effectiveness of Sacubitril and Valsartan compared to Enalapril in reducing the occurrence of CV death.*
FDA Label Image

554 (Sacubitril Valsartan Fig 3c)

554 (Sacubitril Valsartan Fig 3c)
This text provides information on the time to first occurrence of heart failure hospitalizations in the PARADIGM-HF study. It includes data on the failure rate, number at risk, and hazard ratio comparing sacubitril & valsartan with enalapril. The graph shows the number at risk over different time intervals since randomization in days. The hazard ratio for sacubitril & valsartan compared to enalapril is 0.79 with a 95% confidence interval of (0.71, 0.89). This data is valuable for evaluating the effectiveness of the medications in reducing heart failure hospitalizations.*
FDA Label Image

565 (Sacubitril Valsartan Fig 4)

FDA Label Image

989 (Sacubitril Valsartan Fig 5)

989 (Sacubitril Valsartan Fig 5)
This is a description of a study related to heart failure hospitalization and cardiovascular death in the PARAGON-HF trial. The data presented shows the number of events over time since randomization in days for two groups: one group receiving sacubitril and valsartan, and the other group receiving valsartan alone. The study includes a total of 2407 participants in the sacubitril valsartan group and 5389 participants in the valsartan group.*
FDA Label Image

565 (Sacubitril Valsartan Fig 6)

FDA Label Image

656 (Sacubitril Valsartan Fig 7)

FDA Label Image

565 (Sacubitril Valsartan Structure)

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