Inpefa
Product Images NDC 70183-240

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Inpefa (NDC 70183-240). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lexicon Pharmaceuticals, Inc., 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

Structural Formula (Sot00 0005 01)

Chemical structure of INPEFA, showing its molecular arrangement with chlorine, sulfur, oxygen, and hydrogen atoms labeled in a typical chemical diagram format. The image highlights the compound's detailed bonding and atomic connectivity relevant to the pharmaceutical ingredient.*

FDA Label Image

Figure 1 (Sot00 0005 02)

A forest plot chart showing the geometric mean ratios of various drugs relative to sotagliflozin alone, expressed as percentages with 90% confidence intervals. The drugs listed include Metformin (1000 mg, single dose), Ortho-Cyclen (0.25 mg NO + 0.035 mg EE, multiple dose), Mefenamic acid (250 mg, multiple dose), Rifampicin (600 mg, multiple dose), Hydrochlorothiazide (25 mg, multiple dose), and Ramipril (5 mg, multiple dose). The chart compares Cmax and AUC0-last parameters for each drug, illustrating their change relative to medication alone.*

FDA Label Image

Figure 2 (Sot00 0005 03)

A forest plot chart showing the geometric mean ratio relative to drug alone with 90% confidence intervals for various drugs at specified doses. The chart compares the parameters Cmax and AUClast (and AUCtau for some drugs) with percentage values and confidence intervals, indicating changes relative to medication alone for drugs including Metformin, Ortho-Cyclen, Digoxin, Metoprolol, Midazolam, Rosuvastatin, Hydrochlorothiazide, and Ramipril.*

FDA Label Image

Figure 3 (Sot00 0005 04)

A line graph depicting estimated cumulative events per 100 patients over 18 months since randomization, comparing two treatment arms: placebo and sotagliflozin. The x-axis shows time in months, and the y-axis shows cumulative event counts. The graph includes a table of number at risk below, listing patient counts for each group over time.*

FDA Label Image

Figure 4 (Sot00 0005 05)

A forest plot chart comparing events per 100 patient-years (PY) between Sotagliflozin and placebo across various subgroups including sex, age, LVEF percentage at screening, baseline NT-proBNP levels, MRA use at baseline, and timing of first dose. The chart shows hazard ratios (HR) with 95% confidence intervals, illustrating the relative effectiveness of Sotagliflozin versus placebo among different patient groups.*

FDA Label Image

Figure 5 (Sot00 0005 06)

A line graph comparing estimated cumulative events per 100 patients over 24 months since randomization for two treatment arms: placebo and sotagliflozin. The graph displays a consistently lower event rate for sotagliflozin versus placebo, with a hazard ratio of 0.75 (95% CI, 0.63-0.88), and includes a table of patient numbers at risk over time for each group.*

FDA Label Image

Figure 6 (Sot00 0005 07)

A forest plot illustrating hazard ratios (HR) with 95% confidence intervals (CI) for various subgroups comparing events per 100 patient-years between Sotagliflozin and placebo. Subgroups include overall population, sex, age groups, baseline eGFR ranges, history of cardiovascular disease (CVD), history of heart failure (HF) at baseline, and left ventricular ejection fraction (LVEF) at screening. Each subgroup displays event rates for Sotagliflozin and placebo, with HR values represented by squares and CI shown as horizontal lines.*

FDA Label Image

Principal Display Panel – 30 Count 200 mg Bottle Label (Sot00 0005 08)

The label for Inpefa 200 mg sotagliflozin tablets shows the product name, strength, and dosage form. It states "30 Tablets for oral use" and includes a note to dispense with the enclosed medication guide. The label lists Lexicon Pharmaceuticals, Inc. as the manufacturer and includes storage instructions with recommended temperature ranges.*

FDA Label Image

Principal Display Panel – 30 Count 400 mg Bottle Label (Sot00 0005 09)

Label for INPEFA 400 mg sotagliflozin tablets by Lexicon Pharmaceuticals, Inc. The label states 400 mg strength with 30 tablets for oral use. It includes storage instructions, dosing note to see prescribing information, and cautions against cutting, crushing, or chewing the tablets. The label also shows the NDC 70183-240-30 and indicates Rx only.*

* 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.