Farxiga
Product Images NDC 55154-6933

13 FDA label images from Cardinal Health 107, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Farxiga (NDC 55154-6933). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cardinal Health 107, 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

Figure 4

Figure 4
A line graph comparing the percentage of patients with an event over time between FARXIGA and placebo groups. The x-axis shows months from randomization (0 to 60), and the y-axis shows patients with events as a percentage. Two lines represent FARXIGA and placebo, with placebo showing a higher percentage over time. Below the graph is a table listing the number of patients at risk for each group at various time points.*
FDA Label Image

Figure 5

Figure 5
A line graph comparing the percentage of patients with an event over months from randomization for FARXIGA versus Placebo. The x-axis represents months from 0 to 60, and the y-axis shows the percentage of patients with an event, ranging from 0 to 4.5%. Two survival curves are plotted: a solid line for FARXIGA and a dotted line for Placebo. Patient counts at risk for both groups are listed below the x-axis across time points.*
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Figure 6a

Figure 6a
A line graph comparing the percentage of patients experiencing an event over 24 months between FARXIGA and placebo groups. The y-axis represents patients with event (%) from 0 to 30%, and the x-axis shows months from randomization from 0 to 24. The FARXIGA group shows a consistently lower percentage than placebo, with hazard ratio and statistical significance noted. Patient counts at risk decrease over time for both groups.*
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Figure 6b

Figure 6b
A Kaplan-Meier curve comparing the percentage of patients with an event over 24 months from randomization between FARXIGA and placebo groups. The y-axis shows patients with event (%) and the x-axis shows months from randomization. The graph includes patient counts at risk for both groups at various time points, with FARXIGA showing fewer events than placebo. Hazard ratio and confidence interval data are also displayed.*
FDA Label Image

Figure 6c

Figure 6c
A Kaplan-Meier curve comparing the percentage of patients with an event over 24 months from randomization between FARXIGA and placebo groups. The plot shows fewer patients with events in the FARXIGA group than placebo. Below the plot, the number of patients at risk at various time points is listed for both groups. The chart highlights hazard ratio (HR) and statistical significance comparing FARXIGA to placebo.*
FDA Label Image

Figure 7

Figure 7
A forest plot chart showing hazard ratios (HR) with 95% confidence intervals comparing FARXIGA versus placebo across various patient characteristics, including age, sex, race, geographic region, NYHA class, LVEF, NT-proBNP levels, prior hospitalization for heart failure, MRA use, type 2 diabetes status, atrial fibrillation or flutter, heart failure etiology, BMI, and baseline eGFR. The chart visually represents whether FARXIGA or placebo performed better in each subgroup.*
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Dapagliflozin Chemical Structure (Dapagliflozin Struct)

Dapagliflozin Chemical Structure (Dapagliflozin Struct)
Chemical structure of the active ingredient in FARXIGA, showing a detailed molecular diagram including hydroxyl groups, a chlorine atom, and an ethoxy group, as well as associations with an alcohol and water molecules.*
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Farxiga Figure 1 (Farxiga Fig1)

Farxiga Figure 1 (Farxiga Fig1)
A pharmacokinetic curve showing dapagliflozin dose (mg) on the x-axis plotted against change from baseline (CFB) in 24-hour urinary glucose (g) on the y-axis. The graph includes observed values and fitted lines for both healthy subjects and subjects with type 2 diabetes mellitus (T2DM), depicting differing urinary glucose excretion responses by dose.*
FDA Label Image

Figure 8

Figure 8
A Kaplan-Meier curve graph showing the percentage of patients with events over 32 months from randomization, comparing FARXIGA and placebo groups. The graph includes risk table data displaying the number of patients at risk at various time points for both FARXIGA and placebo groups. The hazard ratio (HR) with 95% confidence interval and P-value are indicated for FARXIGA versus placebo.*
FDA Label Image

Image 01

Image 01
A line graph showing adjusted mean change in HbA1c (%) from baseline over 24 weeks for treatments FARXIGA 10 mg + Metformin, FARXIGA 10 mg, and Metformin alone. The x-axis represents study weeks, and the y-axis shows HbA1c percent change. Data include longitudinal repeated measures and adjusted mean changes with 95% confidence intervals at Week 24 (LOCF).*
FDA Label Image

Image 02

Image 02
A line graph comparing the adjusted mean change from baseline in HbA1c (%) over 24 study weeks between two groups: Placebo + Metformin and Farxiga 10 mg + Metformin. The vertical axis shows HbA1c percentage change, and the horizontal axis shows study weeks from 0 to 24. An additional bar displays Week 24 data with 95% confidence intervals for both groups.*
FDA Label Image

Image 03

Image 03
FARXIGA 5 mg tablet bottle label by Cardinal Health 107, LLC. The label states it contains approximately 1440 dapagliflozin tablets, marked Rx only, with medication guide dispense instructions. It includes storage instructions and warnings, a barcode, and distributor details in Sweden.*
FDA Label Image

Image 04

Image 04
FARXIGA 10 mg tablets packaging label showing the active ingredient dapagliflozin. The label indicates a supply of approximately 840 tablets and includes warnings such as 'Rx ONLY' and 'Keep out of reach of children.' The labeler is Cardinal Health 107, LLC. Barcode and dispensing instructions to provide a medication guide are also visible.*

* 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.