Sacubitril And Valsartan Tablet, Film Coated
Product Images NDC 82293-028

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 82293-028). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novugen Pharma (usa) 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

Figure 1 (Figure0001)

A chart presenting the geometric mean ratio and 90% confidence interval for different coadministered drugs relative to a reference. It plots AUC and Cmax values for drugs including furosemide, warfarin, digoxin, carvedilol, levonorgestrel, ethinyl estradiol, amlodipine, HCTZ, metformin, atorvastatin, and sildenafil. The x-axis shows change relative to reference values.*

FDA Label Image

Image Description (Figure0003)

Three Kaplan-Meier cumulative failure rate plots show clinical study data comparing Sacubitril and Valsartan Tablets with Enalapril. Figure A depicts time to first occurrence of cardiovascular death or heart failure hospitalizations. Figure B shows time to occurrence of cardiovascular death. Figure C represents time to first occurrence of heart failure hospitalizations. Each graph includes hazard ratios with 95% confidence intervals and number of patients at risk over time since randomization (days).*

FDA Label Image

Image Description (Figure0004)

A forest plot comparing the hazard ratio for subgroups of patients using Sacubitril and Valsartan tablets versus Enalapril. The chart details multiple patient subgroups such as age, gender, weight, race, NYHA class, diabetes status, blood pressure, ejection fraction, atrial fibrillation, and prior medication use, showing their corresponding event counts, percentages, and hazard ratios with 95% confidence intervals.*

FDA Label Image

Image Description (Figure0005)

A line graph comparing the mean number of total heart failure hospitalizations and cardiovascular deaths per 100 patients over time between Sacubitril and Valsartan Tablets and Valsartan alone. The graph shows data across 1440 days post-randomization, with Sacubitril and Valsartan Tablets consistently lower than Valsartan. A risk table below details patient counts at various time points for both groups.*

FDA Label Image

Image Description (Figure0006)

A forest plot comparing the efficacy of Sacubitril and Valsartan tablets versus Valsartan across various subgroups by age, gender, race, region, diabetic status, LVEF, AF history, NT-proBNP levels, SBP, MRAs use, ACEi intolerance, baseline eGFR, and NYHA class. The plot displays rate ratios with 95% confidence intervals indicating relative effectiveness.*

FDA Label Image

Image Description (Figure0007)

A chart comparing hazard ratios of Sacubitril versus enalapril and Sacubitril versus valsartan in Valsartan tablets. The x-axis represents left ventricular ejection fraction at screening (%), and the y-axis shows the hazard ratio with confidence intervals for two clinical studies, PARADIGM-HF and PARAGON-HF.*

FDA Label Image

Figure 2 (Figure02)

A chart depicting the geometric mean ratio and 90% confidence intervals comparing AUC and Cmax changes for LBQ657 and Valsartan relative to reference among various population subgroups. Subgroups include renal and hepatic impairment levels, age, sex, and race comparisons such as Asian versus Caucasian and Black versus Caucasian.*

FDA Label Image

24mg/26mg Blister (Image0003)

Sacubitril and Valsartan 24 mg/1 mg film-coated tablet labels from Novugen Pharma (USA) LLC. Each label shows the proprietary and generic names, strength, dosage form, manufacturer, barcode, lot number placeholder, and expiration date placeholder. The labels are arranged in a perforated sheet format for packaging.*

FDA Label Image

49mg/51mg Blister (Image0007)

Label for Sacubitril and Valsartan tablet, film coated, 49 mg/51 mg strength, manufactured by Novugen Pharma (USA) LLC. The label includes the proprietary and generic names, dosage form, strength highlighted in blue, barcode, lot number placeholder, expiration date placeholder, and indicates oral use and USA manufacturing.*

FDA Label Image

24mg/26mg 60's (Image001)

Label for Sacubitril and Valsartan Tablets 24 mg/26 mg, film-coated oral tablets, containing 60 tablets per package. The label shows the dosage strength, NDC 82293-027-10, and instructions for storage and child resistance. It is distributed by Novugen Pharma (USA) LLC.*

FDA Label Image

97 mg/103 mg Carton (Image0012)

Packaging label for Sacubitril and Valsartan Tablets, 97 mg/103 mg film-coated tablets. The label shows a box containing 100 tablets (10 x 10 count unit-dose) distributed by Novugen Pharma (USA) LLC, made in India. It includes storage instructions, dosage form, and a barcode.*

FDA Label Image

I24mg/26mg 180's (Image002)

Packaging label for Sacubitril and Valsartan Tablets 24 mg/26 mg film-coated tablets by Novugen Pharma (USA) LLC. The package contains 180 tablets and is labeled Rx only. Label includes dosage strength, distribution details, storage instructions, and barcodes.*

FDA Label Image

49mg/51mg 60's (Image005)

Label for Sacubitril and Valsartan Tablets 49 mg/51 mg, film-coated oral tablets. The package contains 60 tablets and is labeled for prescription use only by Novugen Pharma (USA) LLC. It includes storage instructions, dosage information guidance, barcodes, and a 2D data matrix area for batch details and serial numbers.*

FDA Label Image

49mg/51mg 180's (Image006)

Label for Sacubitril and Valsartan Tablets, 49 mg/51 mg strength, film-coated oral tablets. The label indicates a package size of 180 tablets, distributed by Novugen Pharma (USA) LLC. The label includes storage instructions, dosage information refers to prescribing information, and an NDC code of 82293-028-20 is present.*

FDA Label Image

97 mg/103 mg (60's)

Sacubitril and Valsartan Tablets 97 mg/103 mg film-coated tablet label from Novugen Pharma (USA) LLC. The label indicates a package of 60 tablets with storage instructions and batch barcode. It notes the product is for prescription use only and distributed from Princeton, NJ. The label includes dosage component details and a child-resistant package warning.*

FDA Label Image

97 mg/103 mg (180's)

Label for Sacubitril and Valsartan Tablets, film-coated, 97 mg/103 mg strength. The label states a package size of 180 tablets for oral use, distributed by Novugen Pharma (USA) LLC, made in India. Storage instructions, dosage guidance, and child safety warnings are also included. Barcodes and a QR code area are present on the right side.*

FDA Label Image

97 mg/103 mg Blister (Image011)

This image shows a sheet of ten individual labels for Sacubitril and Valsartan 97 mg/103 mg film-coated tablets. Each label includes the product name, strength, dosage form, lot number placeholder, expiration date placeholder, barcode, and labeler information for Novugen Pharma (USA) LLC. The labels are intended for human prescription drug packaging.*

FDA Label Image

24 mg/26 mg (carton)

The packaging label for Sacubitril and Valsartan Tablets shows a film-coated oral tablet with a strength of 24 mg/26 mg. The label is for a 100-count package (10 x 10 count unit-dose) and is distributed by Novugen Pharma (USA) LLC. The label includes storage instructions and the statement 'Rx only.' The package is marked as not child-resistant and made in India.*

FDA Label Image

49mg/51mg Carton (Image08)

Packaging label for Sacubitril and Valsartan Tablets 49 mg/51 mg from Novugen Pharma (USA) LLC. The label indicates the product is oral film-coated tablets, available in a carton of 100 tablets (10 x 10 count unit-dose). Storage instructions and dosage caution are included alongside the barcode and manufacturer details. The label is marked Rx only and states the package is not child-resistant.*

FDA Label Image

Sacubitril Sodium (Structure0001)

Chemical structure of Sacubitril and Valsartan, showing its molecular arrangement with annotated chiral centers (S) and (R). The structure includes aromatic rings and ester groups characteristic of this active ingredient combination.*

FDA Label Image

Valsartan Disodium (Structure0002)

Chemical structure diagram of the active ingredient Sacubitril and Valsartan, showing its molecular configuration including aromatic rings, nitrogen groups, and sodium salts with associated water molecules.*

* 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.