Sacubitril And Valsartan Tablet, Film Coated
Product Images NDC 84386-081

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 84386-081). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Chemical Structure (Sacubitril Str)

Chemical structure diagram of Sacubitril and Valsartan with sodium salts, showing the molecular arrangement of the two active ingredients in the medication produced by Aurobindo Pharma Limited.*

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Figure1 (Sacubitril Fig1)

A forest plot chart titled 'Coadministered Drugs' showing the geometric mean ratio and 90% confidence intervals for multiple drugs (Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amlodipine, HCTZ, Metformin, Atorvastatin, Sildenafil). Data points represent AUC (solid circles) and Cmax (open circles) values, plotted relative to reference on a horizontal scale from 0.5 to 2.*

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Figure2 (Sacubitril Fig2)

A chart showing the geometric mean ratio and 90% confidence intervals for AUC and Cmax comparing LBQ657 and Valsartan in various population groups with renal and hepatic impairment, age, sex, and race. The vertical axis lists population descriptions, while the horizontal axes display change relative to reference values. Data points for LBQ657 and Valsartan are marked respectively for each group.*

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Figure 5 (Sacubitril Fig5)

A line chart titled 'Total Heart Failure Hospitalizations and CV Death in PARAGON-HF' showing the mean number of events per 100 patients over time in days since randomization. Two lines compare Valsartan and Sacubitril and Valsartan, with Sacubitril and Valsartan consistently showing fewer events. The x-axis represents time up to 1440 days, and the y-axis represents the mean number of events, going up to 60. The chart includes the number of patients at risk for each treatment group at various time points.*

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Figure 6 (Sacubitril Fig6)

A forest plot chart comparing Sacubitril and Valsartan versus Valsartan in various patient subgroups, showing event rates with rate ratio estimates and 95% confidence intervals. The vertical axis lists subgroups by age, gender, race, region, diabetic status, LVEF, atrial fibrillation status, NT-proBNP levels, blood pressure, MRA use, ACEI intolerance, eGFR, and NYHA class. The horizontal axis represents the rate ratio, with markers indicating the comparative effectiveness range between Sacubitril and Valsartan and Valsartan alone.*

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Figure7 (Sacubitril Fig7)

A combined line chart comparing hazard ratios with 95% confidence intervals for Sacubitril and Valsartan versus enalapril (PARADIGM-HF) and versus valsartan (PARAGON-HF) across different left ventricular ejection fraction percentages at screening. The x-axis represents left ventricular ejection fraction (%) and the y-axis shows the hazard ratio values.*

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Figure 3: Kaplan-meier Curves For The Primary Composite Endpoint (a), Cardiovascular Death (b), And Heart Failure Hospitalization (c) (Sacubitril Fig3)

Three Kaplan-Meier cumulative failure rate graphs showing outcomes in PARADIGM-HF comparing Sacubitril and Valsartan with Enalapril. Figure A depicts time to first occurrence of cardiovascular death or heart failure hospitalizations. Figure B shows time to cardiovascular death only. Figure C illustrates time to first heart failure hospitalizations. Each graph includes patient risk numbers at various time points and hazard ratios with confidence intervals.*

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Figure 4: Primary Composite Endpoint (cv Death Or Hf Hospitalization) (Subgroup Analysis)

A forest plot comparing hazard ratios with 95% confidence intervals for Sacubitril and Valsartan versus Enalapril across various subgroups of a study population. Subgroups include age, gender, weight, race, region, NYHA class, kidney function, diabetes, blood pressure, ejection fraction, atrial fibrillation, biomarkers, hypertension, prior medication use, hospitalization history, heart failure duration, cause of heart failure, and ICD use. The graph presents the relative effect size for each subgroup between treatments.*

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Package Label-principal Display Panel (25 mg/26 mg (60 Tablets Bottle))

Label for Sacubitril and Valsartan tablets, film-coated, strength 24 mg/26 mg. The label shows 60 tablets and includes storage instructions, distributor information (Aurobindo Pharma USA, Inc.), and an image of a white, oval tablet marked "50." The product is made in India by Aurobindo Pharma Limited.*

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Package Label-principal Display Panel (24 mg/26 mg Blister Carton (10 x 10 Unit-dose))

Packaging label for Sacubitril and Valsartan Tablets 24 mg/26 mg by Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. The label shows a unit-dose carton containing 100 tablets (10 x 10), film-coated for oral use. The label includes dosage strength, storage instructions, batch and serialization info, and distribution details with addresses in India and the USA.*

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Package Label-principal Display Panel (49 mg/51 mg (60 Tablets Bottle))

Label for Sacubitril and Valsartan Tablets 49 mg/51 mg, film-coated tablets, oral use. The package contains 60 tablets. The label shows actual tablet size and is distributed by Aurobindo Pharma USA, Inc. It includes storage instructions and manufacturing origin in India. Barcode and NDC 84386-082-60 are visible.*

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Package Label-principal Display Panel (49 mg/51 mg (60 Tablets Bottle))

Packaging label for Sacubitril and Valsartan Tablets 49 mg/51 mg by Aurobindo Pharma Limited. The label indicates the product is Rx only and contains 100 unit-dose tablets (10 x 10). It shows the NDC number 84386-082-78 and includes storage instructions, active ingredient information, and distributor details for Aurobindo Pharma USA, Inc.*

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Package Label-principal Display Panel (97 mg/103 mg (60 Tablets Bottle))

Label for Sacubitril and Valsartan Tablets 97 mg/103 mg film-coated tablets, prescription drug, packaged with 60 tablets. The label includes the NDC 84386-083-60 and shows an actual size image of a single oblong white tablet with "200" debossed. Distributed by Aurobindo Pharma USA, Inc., made in India. Storage instructions and a barcode are also visible.*

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Package Label-principal Display Panel (97 mg/103 mg Blister Carton (10 x 10 Unit-dose))

Packaging label for Sacubitril and Valsartan tablets, film coated, strength 97 mg/103 mg. The label states the product is Rx only, packaged as 100 (10 x 10) unit-dose tablets. The labeler is Aurobindo Pharma Limited, with distribution by Aurobindo Pharma USA, Inc. The label includes storage instructions, a barcode, and an image of the tablet shown actual size.*

* 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.