Losartan Potassium Tablet, Film Coated
Product Images NDC 71610-439

12 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · 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 Losartan Potassium (NDC 71610-439). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, 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

Bottle Label 25 mg (71610 0439 30)

Bottle Label 25 mg (71610 0439 30)
Label for Losartan Potassium 25 mg film-coated tablets. The label indicates an oral tablet dosage form with 30 tablets per container. It is labeled for prescription use only (RX Only) and manufactured by Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN. Storage instructions include keeping between 20-25 degrees Celsius in a tight, light-resistant container and out of reach of children. The lot number and expiration date are printed along with a barcode and QR code.*
FDA Label Image

Bottle Label 50 mg (71610 0440 30)

Bottle Label 50 mg (71610 0440 30)
Losartan Potassium USP 50 mg film-coated tablets label for a package of 30 tablets. The label includes storage instructions, dispensing requirements, and manufacturer information: Ascent Pharmaceuticals, Inc. and Aphena Pharma Solutions - Tennessee, LLC. The label specifies oral route and prescription-only status.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure-1 (Losartan Fig1)

Figure-1 (Losartan Fig1)
A line graph comparing the percentage of patients with a primary endpoint over a 66-month study period for Losartan Potassium and Atenolol. The x-axis represents the study months, and the y-axis shows the percentage of patients. The graph indicates an adjusted risk reduction of 13% for Losartan Potassium compared to Atenolol, with a p-value of 0.021.*
FDA Label Image

Figure-2 (Losartan Fig2)

Figure-2 (Losartan Fig2)
A line graph comparing the percentage of patients with fatal/non-fatal stroke over 66 study months for Atenolol and Losartan Potassium. The graph shows adjusted risk reduction of 25% for Losartan Potassium, with p=0.001, indicating a lower stroke incidence compared to Atenolol over time.*
FDA Label Image

Figure-3 (Losartan Fig3)

Figure-3 (Losartan Fig3)
A figure titled 'Primary Endpoint Events within Demographic Subgroups' comparing Losartan Potassium and Atenolol across various subgroups for primary composite events and stroke (fatal/non-fatal) events. The chart includes hazard ratios with 95% confidence intervals, event rates (%), and subgroup categories such as age, gender, race, ISH, diabetes, and history of CVD. Symbols represent sample sizes, and the figure is adjusted for baseline Framingham risk scores and left ventricular hypertrophy.*
FDA Label Image

Figure-4 (Losartan Fig4)

Figure-4 (Losartan Fig4)
A line graph comparing the percentage of patients with an event over 48 months between Losartan Potassium and placebo groups. The graph shows a risk reduction of 16.1% associated with Losartan Potassium treatment, with a p-value of 0.022, indicating statistical significance.*
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Structure (Losartan Struct)

Structure (Losartan Struct)
Chemical structure diagram of losartan potassium showing its molecular arrangement, including the potassium ion.*
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Table-2 (Losartan Table2)

Table-2 (Losartan Table2)
A data table titled 'Pharmacokinetic Parameters in Hypertensive Adults and Children Age 6-16 Following Multiple Dosing.' It compares pharmacokinetic parameters such as AUC0-24, Cmax, T1/2, Tpeak, and CLren between adults given 50 mg once daily for 7 days and children aged 6-16 given 0.7 mg/kg once daily for 7 days. The table includes mean values with standard deviations or medians.*
FDA Label Image

Table-3 (Losartan Table3)

Table-3 (Losartan Table3)
Table showing the incidence of primary and secondary endpoint events comparing Losartan Potassium and Atenolol. It includes event counts, rates per 1000 patient-years, risk reductions, confidence intervals, and p-values for outcomes such as stroke, myocardial infarction, and cardiovascular mortality.*
FDA Label Image

Table-4 (Losartan Table4)

Table-4 (Losartan Table4)
A data table titled 'Table 4: Incidence of Primary Endpoint Events' compares the incidence rates, risk reduction percentages, 95% confidence intervals, and p-values for Losartan and placebo groups in various outcomes, including primary composite endpoint, doubling of serum creatinine, ESRD, and death, as first events and overall incidence.*
FDA Label Image

Table-5 (Losartan Table5)

Table-5 (Losartan Table5)
A data table titled 'Efficacy Outcomes within Demographic Subgroups' showing the number of patients, event rates, and hazard ratios with 95% confidence intervals for Losartan Potassium versus placebo. Data is stratified by overall results, age, gender, and race, with columns for primary composite endpoint and ESRD event rates and hazard ratios.*

* 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.