Structural Formula (Sot00 0005 01)
Inpefa Tablet
Product Images NDC 70183-221
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Inpefa (NDC 70183-221). 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.
Product Images & Figures Index
Figure 1 (Sot00 0005 02)
Figure 2 (Sot00 0005 03)
Figure 3 (Sot00 0005 04)
This appears to be a table representing clinical trial data comparing a treatment arm (Sotagliflozin) versus a placebo arm for some sort of medical condition. The table includes estimated cumulative events per 100 patients and hazard ratios with associated confidence intervals and P-values. Time is also represented on the x-axis in months since randomization. There is not enough information to determine what medical condition is being studied.*
Figure 4 (Sot00 0005 05)
Figure 5 (Sot00 0005 06)
This is a clinical trial data comparing the efficacy of a placebo arm versus sotagliflozin arm in treating an unknown medical condition affecting 100 patients. The table shows the hazard ratio for the sotagliflozin arm versus the placebo arm. The number of patients at risk is also provided for each arm at different time points since randomization.*
Figure 6 (Sot00 0005 07)
This is a table of medical data, including patient gender, age, number of patients, baseline cGFR, history of CVD and HE, and LVEF at screening. There are also some numerical values and percentages that are likely related to medical tests or procedures, but without additional context, it is difficult to determine their meaning.*
Principal Display Panel – 30 Count 200 mg Bottle Label (Sot00 0005 08)
This is a medication called "sotagliflozin" manufactured by Lexicon Pharmaceuticals. Each tablet contains 200 mg of the medication. The recommended dosage information is available in the prescribing information. The tablets should be swallowed whole and should not be cut, crushed, or chewed. The medication should be stored at the temperature range of 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). It is only for prescription use and should be kept out of the reach of children. The remaining information contains lot, expiry, and serialization information.*
Principal Display Panel – 30 Count 400 mg Bottle Label (Sot00 0005 09)
Each tablet of this medication contains 400 mg of sotaglilozin and comes in a package with NDC 70183-240-30 XOOO0KKK. The recommended dosage must be obtained from the prescribing information. The tablets should be swallowed whole and should not be cut, crushed or chewed. They must be stored in a cool and dry place between 20°C to 25°C (68°F to 77°F), but brief excursions are permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. This is a medication for oral use and comes in a package of 30 tablets. It is important to keep it out of reach of children. The manufacturer is Lexicon Pharmaceuticals, Inc. located in The Woodlands, TX 77381.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
