Irbesartan And Hydrochlorothiazide Tablet
Product Images NDC 0054-0255

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Irbesartan And Hydrochlorothiazide (NDC 0054-0255). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa Inc., 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

Figure1a.jpg (Figure1a)

A line graph showing the percentage of patients with systolic blood pressure (SBP) below 140 mmHg versus baseline SBP (mmHg). The legend differentiates results from various studies involving Irbesartan (Irb.), Hydrochlorothiazide (HCTZ), and their combination (Irb.-HCTZ) across Study V and Study VI, represented by different line styles and thicknesses.*

FDA Label Image

Figure1b.jpg (Figure1b)

A line graph showing the percentage of patients with systolic blood pressure (SBP) below 130 mmHg plotted against baseline SBP (mmHg). The graph includes five distinct lines representing different studies with Irbesartan (Irb), Hydrochlorothiazide (HCTZ), or their combination (Irb.-HCTZ) from Study V and Study VI, each identified by different line styles in the legend.*

FDA Label Image

Figure2a.jpg (Figure2a)

A line graph depicting % diastolic blood pressure (DBP) less than 90 mmHg versus baseline DBP (mmHg) for studies involving Irbesartan and Hydrochlorothiazide (Irb.-HCTZ) and Irbesartan (Irb.) alone from Study V and Study VI. Different line styles represent the combination therapy and individual components across the two studies.*

FDA Label Image

Figure2b.jpg (Figure2b)

A line graph showing the percentage of diastolic blood pressure (DBP) less than 80 mmHg versus baseline DBP values (mmHg). Multiple lines represent different studies: Irbesartan and Hydrochlorothiazide combination (Irb.-HCTZ) from Study V and Study VI, Irbesartan (Irb.) alone from Study V and VI, and Hydrochlorothiazide (HCTZ) from Study V. The graph compares the outcomes across these treatment groups.*

FDA Label Image

Figure3.jpg (Figure3)

A scatter plot with a fitted curve illustrating the relationship between Irbesartan Dose (mg/day) on the x-axis and a measured parameter in mmHg on the y-axis. Data points are scattered with indication of variability, highlighting dose-dependent response up to around 750 mg/day.*

FDA Label Image

Figure4.jpg (Figure4)

A scatter plot with a fitted curve showing the relationship between Irbesartan dose (mg/day) on the x-axis and a response measured in mmHg on the y-axis, ranging from -2 to 8 mmHg. Data points are scattered and the curve rises steeply at lower doses then plateaus around 7 mmHg at higher doses.*

FDA Label Image

Hydrochlorothiazide.jpg (Hydrochlorothiazide)

Chemical structure of Hydrochlorothiazide, one of the active ingredients in the combination drug Irbesartan and Hydrochlorothiazide by Hikma Pharmaceuticals USA Inc. The structure shows a benzothiadiazine ring with chlorine, sulfonamide, and amine functional groups.*

FDA Label Image

Fpl-bl-150mgper12pt5mg-30tab-02.jpg (Fpl Bl 150mgper12pt5mg 30tab 02)

Label for Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg strength. The label includes the NDC 0054-0254-13 and indicates a package of 30 tablets. It features storage instructions to keep at 20° to 25°C and notes distribution by West-Ward Pharmaceuticals Corp., Eatontown, NJ. The label also states to see the package insert for complete prescribing information and marks the product as Rx only.*

FDA Label Image

Fpl-bl-300mgper12pt5mg-30tab-02.jpg (Fpl Bl 300mgper12pt5mg 30tab 02)

Label for Irbesartan and Hydrochlorothiazide Tablets USP, 300 mg/12.5 mg strength. The label indicates a package containing 30 tablets with an NDC of 0054-0255-13, distributed by West-Ward Pharmaceuticals Corp. Dosage instructions direct to see the package insert, and storage conditions specify 20° to 25°C (68° to 77°F). A barcode is included on the right side.*

FDA Label Image

Structure.jpg (Structure)

Chemical structure of Irbesartan, an active ingredient in the combination drug Irbesartan and Hydrochlorothiazide by Hikma Pharmaceuticals USA Inc. The diagram shows the molecular formula with rings and functional groups clearly illustrated.*

* 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.