Irbesartan And Hydrochlorothiazide Tablet, Film Coated
Product Images NDC 63187-653

9 FDA label images from Proficient Rx Lp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Irbesartan And Hydrochlorothiazide (NDC 63187-653). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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

63187-653-30 (63187 653 30)

63187-653-30 (63187 653 30)
Label for Irbesartan and Hydrochlorothiazide 150 mg / 12.5 mg film-coated tablets by Proficient Rx LP. The label states each tablet contains 150 mg Irbesartan USP and 12.5 mg Hydrochlorothiazide USP in a peach, oval shape with "ML 34" debossed on one side. Package contains 30 tablets. Manufactured by Macleods Pharmaceuticals Ltd., India, and relabeled by Proficient Rx LP in Thousand Oaks, CA.*
FDA Label Image

Figure1a.jpg (Figure1a)

Figure1a.jpg (Figure1a)
A line graph depicting the relationship between baseline systolic blood pressure (SBP) in mmHg on the horizontal axis and the percentage of patients with SBP less than 140 mmHg on the vertical axis. Multiple study data sets for Irbesartan (Irb) and Hydrochlorothiazide (HCTZ), labeled Study V and VI, are represented with different line styles and markers.*
FDA Label Image

Figure1b.jpg (Figure1b)

Figure1b.jpg (Figure1b)
A line graph showing the percentage of systolic blood pressure (SBP) under 130 mmHg plotted against baseline SBP (mmHg) values ranging from 140 to 220. Five different study groups are represented with distinct line styles, illustrating trends in SBP reduction across baseline SBP levels.*
FDA Label Image

Figure2a.jpg (Figure2a)

Figure2a.jpg (Figure2a)
A line graph comparing the percentage of diastolic blood pressure (DBP) below 90 mmHg against baseline DBP values for four study groups labeled as Irbesartan (Irb), Hydrochlorothiazide (HCTZ), and their combinations in Study V and Study VI.*
FDA Label Image

Figure2b.jpg (Figure2b)

Figure2b.jpg (Figure2b)
A line graph showing the relationship between baseline diastolic blood pressure (DBP, mmHg) on the x-axis and the percentage of DBP <80 mmHg on the y-axis. The graph includes multiple study lines labeled Irb. HCTZ Study V, Irb. Study V, HCTZ Study V, Irb. HCTZ Study VI, and Irb. Study VI, comparing different treatments or conditions related to blood pressure.*
FDA Label Image

Figure3 (Figure3)

Figure3 (Figure3)
A scatter plot with a fitted curve illustrating placebo-subtracted reduction in a measured variable (mmHg) versus Irbesartan dose (mg/day) up to 900 mg/day. Data points scatter above the curve which shows a steep initial increase followed by a plateau, indicating the reduction effect with increasing Irbesartan doses.*
FDA Label Image

Figure4 (Figure4)

Figure4 (Figure4)
A chart showing the placebo-subtracted reduction in trough systolic blood pressure (mmHg) as a function of Irbesartan dose (mg). The graph depicts a curve that rises steeply at lower doses and plateaus at higher doses, illustrating the dose-response relationship.*
FDA Label Image

Hydrochlorothiazide (Hydrochlorothiazide)

Hydrochlorothiazide (Hydrochlorothiazide)
Chemical structure diagram depicting the molecular configuration of the active ingredient, shown as a sulfonamide-containing bicyclic compound with chlorine, nitrogen, oxygen, and sulfur atoms. This structure corresponds to the active components in Irbesartan and Hydrochlorothiazide tablets.*
FDA Label Image

Irbesartan (Irbesartan)

Irbesartan (Irbesartan)
Chemical structure of the active ingredient shown in the product Irbesartan and Hydrochlorothiazide. The diagram illustrates the molecular structure with various carbon, nitrogen, and oxygen atoms and rings corresponding to the compound.*

* 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.