Chemical Structure (Ofev 01)
Ofev Capsule
Product Images NDC 0597-0143
View Photos of 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 Ofev (NDC 0597-0143). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Boehringer Ingelheim 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 (Ofev 02)
Figure 2 (Ofev 03)
Figure 3 (Ofev 04)
The text is describing the Kaplan-Meier estimate of survival for a study with two groups receiving different treatments, Placebo and Nintedanib 150. The number of individuals at risk and the percentage survival rate is shown in a chart over 52 weeks. The Hazard Ratio for Nintedanib vs. Placebo is given as 0.70 with a confidence interval. Some of the data points on the chart are 210, 220, 300, 350, and 373, possibly representing the time in days until death.*
Figure 4 (Ofev 04a)
This appears to be a statistical analysis of the effect of Nintedanib 150bid on different types of Interstitial Lung Diseases with varying subtypes such as Undlassifiable idiopathic interstitial pneumonia, Hypersensitivity pneumonia, Idiopathic nonspecific interstitial pneumonia, and Autoimmune ILDs. The study measures the adjusted rate of decline in forced vital capacity (FVC) over 52 weeks and provides a confidence interval for the difference between Nintedanib 150bid and placebo.*
Figure 5 (Ofev 04b)
Figure 6 (Ofev 04c)
The text appears to be a table showing the percent change from baseline in some values, possibly related to the effects of different drug treatments. There are also numbers indicating the amount of improvement or worsening with each treatment. Some values are missing or not legible.*
Figure 7 (Ofev 05)
This appears to be a table of numerical data displaying the mean forced vital capacity (FVC) in milliliters (mL) and the number of patients for a placebo group and a group taking the medication Nintedanib 150 mg twice daily. There are also several values with negative signs and SEM (standard error of the mean) mentioned, which suggest that this may be a statistical analysis of some sort.*
Figure 8 (Ofev 06)
This information appears to be a table showing regions and numbers related to Mycophenolate use at baseline, along with other metrics such as Deciine and Difference. The table also illustrates a graph, represented as a percentage, of the difference between Placebo rates and Nintedanib rates at 150bid. The graph represents adjusted rate of decline in FVC and includes a 95% confidence interval. There is not enough context to provide any specific insights about what the data represents, but it seems related to medical or clinical research.*
Figure 9 (Ofev 07)
The text provided is a statistical report on the percentage change from baseline in FVC (forced vital capacity in mL) at week 52 for a medication called "Niedanib" compared to a placebo treatment. The percentage changes are denoted in a table with various numerical values under the headings "Placebo" and "Tirteganb 150613". The text also includes a graph showing the proportion (%) of change in FVC over a range of values. There is incomplete text with missing data denoted by the phrase "Missing 1%" .*
Image (Ofev 08)
Principal Display Panel (150 mg Capsule Bottle Carton)
Ofeve (nintedanib capsules) is a medication that comes in a bottle with 60 capsules. Each capsule contains 150mg of nintedanib. The drug is not to be chewed, crushed or opened. The dosage is to be taken as per the package insert. Store the drug at temperatures between 20°C to 25°C (68°F to 77°F) and avoid exposure to high humidity and excessive heat. The medication must be kept away from children and be dispensed in a well-sealed container according to USP. Finally, the product trademark is licensed from Boehringer Ingelheim International GmbH, and it is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., USA.*
Principal Display Panel (100 mg Capsule Bottle Carton)
Nintedanib capsules, sold under the product name Ofeve, contains 100 mg of nintedanib equivalent to 120.20 mg of intedani. It comes in a package of 60 capsules, with the NDC 0597014360 and 0557-0143-60. The medication should be stored between 20°C to 25°C, and should be protected from exposure to high humidity and excessive heat. The trademark is licensed from Boehringer Ingelheim International GmbH and the product is made in Germany. Please refer to the package insert for dosage instructions, and keep out of reach of children. For more information, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1800525257.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
