Irbesartan And Hydrochlorothiazide Tablet, Film Coated
Product Images NDC 33342-057

12 FDA label images from Macleods Pharmaceuticals Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Irbesartan And Hydrochlorothiazide (NDC 33342-057). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Macleods Pharmaceuticals 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

Irbe H 150 12 5 30

Irbe H 150 12 5 30
Label for Irbesartan and Hydrochlorothiazide Tablets USP, film-coated, containing 150 mg Irbesartan and 12.5 mg Hydrochlorothiazide per tablet. The label includes dosage form, storage instructions between 20° to 25°C, manufacturer details Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, and package count of 30 tablets.*
FDA Label Image

Irbe H 150 12 5 90

Irbe H 150 12 5 90
Label for Irbesartan and Hydrochlorothiazide Tablets USP 150 mg/12.5 mg, film-coated oral tablets. The label indicates the product contains 90 tablets and is manufactured by Macleods Pharmaceuticals Limited, with production details listing Macleods Pharma USA, Inc. and Macleods Pharmaceuticals Ltd. Storage instructions specify temperatures between 20° to 25°C with allowed excursions. The label includes NDC 33342-057-10 and features barcodes and dosage information.*
FDA Label Image

Irbe H 300 12 5 30

Irbe H 300 12 5 30
Packaging label for Irbesartan and Hydrochlorothiazide Tablets USP 300 mg/12.5 mg, film-coated oral tablets. The label includes drug strengths, storage instructions, manufacturer information for Macleods Pharmaceuticals Limited and Macleods Pharma USA, and a quantity of 30 tablets. It features barcodes and dosage guidance references.*
FDA Label Image

Irbe H 300 12 5 90

Irbe H 300 12 5 90
Label for Irbesartan and Hydrochlorothiazide Tablets USP 300 mg/12.5 mg film-coated oral tablets. The label indicates each tablet contains 300 mg Irbesartan and 12.5 mg Hydrochlorothiazide. It shows a package size of 90 tablets, manufactured by Macleods Pharmaceuticals Limited and labeled for Macleods Pharma USA, Inc. Storage instructions and dosage advisory reference are also included.*
FDA Label Image

Irbe H Figure1a

Irbe H Figure1a
A line graph showing the relationship between Baseline Systolic Blood Pressure (SBP) in mmHg on the x-axis and the percentage of subjects with SBP less than 140 mmHg on the y-axis. The graph compares different studies involving Irbesartan (Irb) and Hydrochlorothiazide (HCTZ), illustrating treatment effects on blood pressure reduction.*
FDA Label Image

Irbe H Figure1b

Irbe H Figure1b
A line graph depicting the percentage of subjects achieving systolic blood pressure (SBP) less than 130 mmHg versus baseline SBP (mmHg). It compares results across multiple studies involving Irbesartan, Hydrochlorothiazide, and their combination.*
FDA Label Image

Irbe H Figure2a

Irbe H Figure2a
A line graph comparing the percentage change in diastolic blood pressure (DBP) below 90 mmHg against baseline DBP (mmHg) across four different study groups involving Irbesartan (Irb), Hydrochlorothiazide (HCTZ), and their combination in Studies V and VI. The graph shows percentage DBP reduction trends for each treatment and study group over a range of baseline DBP values.*
FDA Label Image

Irbe H Figure2b

Irbe H Figure2b
A line graph showing the percentage of diastolic blood pressure (DBP) less than 80 mmHg plotted against baseline DBP (mmHg). The graph includes multiple lines representing different study groups labeled as Irb. HCTZ Study V, Irb. Study V, HCTZ Study V, Irb. HCTZ Study VI, and Irb. Study VI.*
FDA Label Image

Irbe H Figure3

Irbe H Figure3
A scatter plot with a fitted curve showing the relationship between Irbesartan Dose (mg/day) on the x-axis and the placebo-subtracted reduction in an unspecified measurement (mmHg) on the y-axis. Data points illustrate an increasing effect with higher doses, leveling off at higher dose values.*
FDA Label Image

Irbe H Figure4

Irbe H Figure4
A scientific line graph labeled Figure 4 displaying the placebo-subtracted reduction in trough systolic blood pressure (mmHg) on the vertical axis against the Irbesartan dose (mg/day) on the horizontal axis. The graph shows data points and a curve indicating the relationship of increasing blood pressure reduction with increasing doses of Irbesartan up to around 900 mg/day.*
FDA Label Image

Irbe H Hydrochlorothiazide

Irbe H Hydrochlorothiazide
Chemical structure diagram of the active ingredient Irbesartan and Hydrochlorothiazide, showing atoms and bonds including sulfonamide and chlorinated aromatic groups.*
FDA Label Image

Irbe H Irbesartan

Irbe H Irbesartan
Chemical structure of the active ingredient Irbesartan, showing its molecular framework with labeled functional groups and bonds as depicted in the image.*

* 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.