Sacubitril And Valsartan Tablet, Film Coated
Product Images NDC 42385-931

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 42385-931). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Laurus Labs 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.

FDA Label Image

Figure1 (Sacubitrilvalsartan Figure1)

A chart showing the geometric mean ratio and 90% confidence interval for the pharmacokinetic parameters AUC and Cmax of various coadministered drugs relative to a reference. The chart includes drugs such as Furosemide, Warfarin, Digoxin, Carvedilol, Levonorgestrel, Ethinyl estradiol, Amlodipine, HCTZ, Metformin, Atorvastatin, and Sildenafil, plotted with their change relative to reference on the x-axis.*

FDA Label Image

Package Label.principal Display Panel (49 mg/51 mg)

Sheet of Sacubitril and Valsartan Tablet labels, each indicating the 49 mg/51 mg strength. Labels display the product name, strength, manufacturer Laurus Labs Limited, lot and expiration fields, and a barcode. The labels are intended for prescription human oral film-coated tablets.*

FDA Label Image

Sacubitrilvalsartan-figure11.jpg (Sacubitrilvalsartan Figure11)

Label for Sacubitril and Valsartan Tablets 97 mg/103 mg, film-coated oral tablets. The package contains 30 tablets. Manufactured by Laurus Labs Limited and labeled for Laurus Generics Inc. The label includes storage instructions, dosage strength, and manufacturer address.*

FDA Label Image

Sacubitrilvalsartan-figure12.jpg (Sacubitrilvalsartan Figure12)

Packaging label for Sacubitril and Valsartan Tablets 97 mg/103 mg, film-coated oral tablets. The label indicates the package contains 100 unit-dose tablets (10 x 10). Manufactured by Laurus Labs Limited and labeled for Laurus Generics Inc. The label includes storage instructions and a barcode.*

FDA Label Image

Package Label.principal Display Panel (97 mg/103 mg)

A sheet of film-coated tablet labels for Sacubitril and Valsartan 97 mg/103 mg by Laurus Labs Limited. Each label includes the product name, strength highlighted in green, NDC 42385-932-10, Rx Only designation, manufacturer info, barcode, and blank fields for lot number and expiration date.*

FDA Label Image

Sacubitrilvalsartan-figure14 (Sacubitrilvalsartan Figure14)

A line graph titled 'Total Heart Failure Hospitalizations and CV Death in PARAGON-HF' showing mean number of events per 100 patients over time (days) since randomization. Two lines represent comparisons between Valsartan and Sacubitril and Valsartan treatments, with Sacubitril and Valsartan showing a consistently lower mean number of events. A table below the x-axis shows the number of patients at risk at various time points for each treatment group.*

FDA Label Image

Sacubitrilvalsartan-figure15 (Sacubitrilvalsartan Figure15)

A forest plot comparing the efficacy of Sacubitril and Valsartan versus Valsartan alone across various subgroups, including age, gender, race, region, diabetic status, LVEF, AF history, NT-proBNP levels, SBP, MRA use, ACEI intolerance, eGFR, and NYHA classification. The plot displays rate ratio estimates with 95% confidence intervals indicating the relative benefit for each subgroup.*

FDA Label Image

Sacubitrilvalsartan-figure16 (Sacubitrilvalsartan Figure16)

This image contains two line graphs comparing hazard ratios with 95% confidence intervals for Sacubitril and Valsartan versus enalapril and versus valsartan. The left graph (PARADIGM-HF) plots hazard ratio against left ventricular ejection fraction (%) at screening, while the right graph (PARAGON-HF) similarly plots hazard ratio against ejection fraction for a different comparison group.*

FDA Label Image

Figure2 (Sacubitrilvalsartan Figure2)

A comparative chart illustrating geometric mean ratios and 90% confidence intervals for AUC and Cmax of Sacubitril and Valsartan (LBQ657) relative to reference groups across various population descriptions, including different levels of renal and hepatic impairment, age groups, and ethnicities.*

FDA Label Image

Sacubitrilvalsartan-figure3 (Sacubitrilvalsartan Figure3)

Three Kaplan-Meier curve charts labeled Figure A, B, and C showing time to first occurrence of cardiovascular events and heart failure hospitalizations in a clinical trial comparing Sacubitril and Valsartan versus Enalapril. Each chart plots cumulative failure rate over time since randomization in days, with Sacubitril and Valsartan consistently showing lower event rates. Tables with patient numbers at risk are included below each chart.*

FDA Label Image

Sacubitrilvalsartan-figure4 (Sacubitrilvalsartan Figure4)

A forest plot chart comparing the hazard ratios between Sacubitril and Valsartan versus Enalapril across various subgroups. The subgroups listed include age, gender, weight, race, region, NYHA class, estimated GFR, diabetes status, systolic blood pressure, ejection fraction, atrial fibrillation, NT-proBNP levels, hypertension, prior use of ACE inhibitors, ARBs, aldosterone antagonists, prior heart failure hospitalization, time since diagnosis, cause of heart failure, and ICD use. Each subgroup shows hazard ratios with confidence intervals visually represented by squares and horizontal lines along a central axis indicating whether Sacubitril and Valsartan or Enalapril performed better.*

FDA Label Image

Sacubitrilvalsartan-figure5.jpg (Sacubitrilvalsartan Figure5)

Label for Sacubitril and Valsartan film-coated tablets, strength 24 mg/26 mg, oral dosage form. The pack contains 30 tablets. Manufactured by Laurus Labs Limited and labeled for Laurus Generics Inc. Includes storage instructions and dosage caution. The Laurus Labs logo is shown below the product name.*

FDA Label Image

Sacubitrilvalsartan-figure6.jpg (Sacubitrilvalsartan Figure6)

Box packaging label for Sacubitril and Valsartan Tablets 24 mg/26 mg by Laurus Labs Limited. The label indicates 100 unit-dose film-coated tablets in a carton intended for institutional use only, with storage instructions and manufacturer details including Laurus Generics Inc. and Laurus Labs Limited, India.*

FDA Label Image

Package Label.principal Display Panel (24 mg/26 mg)

Sheet of ten identical labels for Sacubitril and Valsartan Tablet, 24 mg/26 mg strength, film-coated oral tablets. Each label states "Rx Only" and includes the NDC 42385-930-10, manufactured by Laurus Labs Limited. Lot and expiration date fields are blank. Each label features a barcode on the right side.*

FDA Label Image

Sacubitrilvalsartan-figure8.jpg (Sacubitrilvalsartan Figure8)

Label for Sacubitril and Valsartan Tablets 49 mg/51 mg, film-coated oral tablets. The label states the package contains 30 tablets. It is manufactured by Laurus Labs Limited and for Laurus Generics Inc. Storage instructions and dosage directions are partially visible.*

FDA Label Image

Sacubitrilvalsartan-figure9.jpg (Sacubitrilvalsartan Figure9)

Packaging for Sacubitril and Valsartan Tablets, 49 mg/51 mg strength, film-coated oral tablets. The box indicates 100 unit-dose tablets (10x10). Labeler is Laurus Labs Limited, manufactured for Laurus Generics Inc. The packaging includes storage instructions and usage designation as Rx only and for institutional use only.*

FDA Label Image

Sacubitrilvalsartan-structure (Sacubitrilvalsartan Structure)

Chemical structure of Sacubitril and Valsartan, depicting the molecular arrangement including carbon, hydrogen, oxygen, nitrogen atoms, and associated functional groups as part of the compound's skeletal formula.*

* 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.