Nintedanib Capsule
Product Images NDC 0781-2492

This is a data report related to a medical study or clinical trial comparing the effects of Nintedanib 150bid (twice a day) and placebo in patients with various types of interstitial lung diseases (ILDs). The study involved a total population of 331 individuals, including those with autoimmune ILDs, hypersensitivity pneumonitis, idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The report presents estimates of decline in FVC (forced vital capacity) over 52 weeks for each subgroup, with confidence intervals. The data suggest that Nintedanib 150bid may have a beneficial effect compared to placebo in certain ILD subtypes.*

This text provides information about the observed forced vital capacity (FVC) changes from baseline in a study comparing a placebo group to a group taking a medication called Nintedanib at a dose of 150 mg twice a day. The mean (SEM) FVC changes in milliliters are presented, showing numerical values for both groups.*

This text provides data on the mean (SEM) observed Forced Vital Capacity (FVC) [mL] change from baseline in a study comparing a placebo to nintedanib 150bid. The number of patients for each group is also listed. Bid is explained as twice daily dosing. The total number of patients in each group is shown.*

This is a table showing the comparison of Mycophenolate use at baseline and the rate of decline in FVC (Forced Vital Capacity) between Placebo and Nintedanib 150bid in a study across different regions. It provides data on the differences and confidence intervals in the rate of decline in FVC. The text also includes information on the number of participants and the percentage change.*

Not available*

This text is a prescription drug label for Nintedanib capsules, each containing 100 mg of nintedanib, equivalent to 120.40 mg of nintedanib esylate. The dosage instructions should be checked in the package insert. It is recommended not to chew, crush, or open the capsules. The capsules should be stored at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). High humidity and excessive heat exposure should be avoided. The medicine should be kept out of reach of children. The product is from India and distributed by Sandaz Inc., based in Princeton, NJ.*

This text provides information about Nintedanib Capsules, each containing 150 mg of nintedanib equivalent to 180.60 mg of nintedanib esylate. The capsules are for prescription use only and should not be chewed, crushed, or opened. The recommended storage temperature is between 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C - 30°C (59°F to 86°F). It is important to protect the capsules from high humidity and excessive heat and dispense them in a tight container. The product is from India and distributed by Sandaz Inc. in Princeton, NJ. The provided details include the GTIN, LOT, EXP information along with dosage instructions.*