Xigduo Tablet, Film Coated, Extended Release
Product Images NDC 0310-6250

14 FDA label images from Astrazeneca Pharmaceuticals Lp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Xigduo (NDC 0310-6250). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Astrazeneca Pharmaceuticals 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

Figure 4 (Figure 4)

Figure 4 (Figure 4)
A line graph comparing the percentage of patients with event over months from randomization between two groups: Dapagliflozin and Placebo. The x-axis shows months since randomization up to 60 months, and the y-axis shows percentage of patients with event up to 7%. The graph includes patient counts at risk for both groups at several time points.*
FDA Label Image

Figure 5 (Figure 5)

Figure 5 (Figure 5)
A line graph showing the percentage of patients with events over time in months from randomization, comparing dapagliflozin with placebo. The x-axis represents months from randomization up to 60 months, and the y-axis shows the percentage of patients with events ranging from 0 to 4.5%. Two lines depict cumulative patient events, with dapagliflozin showing consistently lower event rates than placebo. Below the graph, numbers of patients at risk at various time points for both dapagliflozin and placebo groups are listed.*
FDA Label Image

Figure 6

Figure 6
A line graph comparing the percentage of patients with an event over 24 months from randomization between dapagliflozin and placebo groups. The y-axis shows patients with event (%) and the x-axis shows months from randomization. The graph includes patient numbers at risk for both groups across time intervals and shows dapagliflozin consistently has a lower event rate than placebo, with a hazard ratio of 0.74 (95% CI: 0.65, 0.85).*
FDA Label Image

Figure 7

Figure 7
A survival plot comparing the percentage of patients with an event over time in months from randomization for dapagliflozin versus placebo. The y-axis shows patients with event (%) from 0 to 24%, and the x-axis shows months from 0 to 32. The graph includes a hazard ratio with 95% confidence interval (HR 0.61, 0.51-0.72). Below the graph, the number of patients at risk for each group is listed at multiple time points.*
FDA Label Image

Dapagliflozin Chemical Structure (Image 01)

Dapagliflozin Chemical Structure (Image 01)
Chemical structure diagram depicting dapagliflozin and metformin hydrochloride with an associated water molecule. The structure shows detailed atom-level connectivity typical of these active ingredients in XIGDUO XR tablets.*
FDA Label Image

Metformin Hydrochloride Chemical Structure (Image 02)

Metformin Hydrochloride Chemical Structure (Image 02)
Chemical structure of dapagliflozin and metformin hydrochloride, the active ingredients in XIGDUO XR extended-release tablets by AstraZeneca Pharmaceuticals LP.*
FDA Label Image

Figure 1 (Image 03)

Figure 1 (Image 03)
A dose-response plot showing dapagliflozin dose (mg) on the x-axis and cumulative excretion in urine of 24-hour urinary glucose (g) on the y-axis. Scatter points differentiate observed values for healthy subjects and subjects with type 2 diabetes mellitus (T2DM). Fitted lines illustrate trends for both groups across varying doses.*
FDA Label Image

Figure 2 (Image 04)

Figure 2 (Image 04)
A line graph depicting the adjusted mean change from baseline in HbA1c (%) over a 24-week study period. The graph compares three treatment groups: dapagliflozin 10 mg plus metformin XR, dapagliflozin 10 mg alone, and metformin XR alone. The x-axis shows study weeks from 0 to 24, and the y-axis shows HbA1c change from baseline. A side graph shows Week 24 last observation carried forward (LOCF) values with 95% confidence intervals for each group.*
FDA Label Image

Figure 3: Graph (Image 05)

Figure 3:  Graph (Image 05)
A line graph comparing adjusted mean changes in HbA1c (%) from baseline over 24 weeks between two groups: one receiving placebo plus metformin, and the other dapagliflozin 10 mg plus metformin. The graph shows a greater HbA1c reduction in the dapagliflozin plus metformin group across study weeks. Error bars with 95% confidence intervals are presented for Week 24 data on the right side.*
FDA Label Image

3941801 (Image 06)

3941801 (Image 06)
Packaging label for XIGDUO XR extended-release tablets containing 2.5 mg dapagliflozin and 1000 mg metformin hydrochloride. The label indicates the package contains 60 tablets, is prescription only, and instructs that tablets must be swallowed whole without crushing, cutting, or chewing. Manufactured by AstraZeneca Pharmaceuticals LP.*
FDA Label Image

3936001 (Image 07)

3936001 (Image 07)
Label for XIGDUO XR extended-release tablets containing dapagliflozin and metformin hydrochloride at 5 mg/500 mg strength. The label shows the product name, active ingredients, dosage form, quantity of 30 tablets, and manufacturer AstraZeneca Pharmaceuticals LP. It includes directions to dispense with medication guide and cautions against crushing, cutting, or chewing the tablets.*
FDA Label Image

3936101 (Image 08)

3936101 (Image 08)
Label for XIGDUO XR tablets containing dapagliflozin and metformin hydrochloride extended-release, 5 mg/1000 mg strength. The label indicates a 60 tablet count, prescription only, with warnings to not crush, cut, or chew and to swallow whole. Distributed by AstraZeneca Pharmaceuticals LP.*
FDA Label Image

3936201 (Image 09)

3936201 (Image 09)
Label for XIGDUO XR tablets containing dapagliflozin and metformin hydrochloride extended-release. Dosage strength is 10 mg/500 mg. The label indicates 30 tablets per package, prescription use only, with instructions not to crush, cut, or chew tablets and to swallow whole. Manufactured by AstraZeneca Pharmaceuticals LP.*
FDA Label Image

3936301 (Image 10)

3936301 (Image 10)
XIGDUO XR (dapagliflozin/metformin HCl extended-release) tablets packaging label showing a 30-count bottle. The label indicates the strength of 10 mg dapagliflozin and 1000 mg metformin HCl per tablet. It includes instructions to dispense with medication guide and a note that tablets must be swallowed whole without crushing, cutting, or chewing. Manufactured by AstraZeneca Pharmaceuticals LP.*

* 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.